Job Postings
AMDM posts open positions within the IVD Industry.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
The is no charge for AMDM Members for a 60-day posting. Non-members are charged $150 (Pay via our secure online store).
AMDM members are notified via email when a new posting is uploaded.
To post your open position, please send your job description (be sure to include how to apply for the position) and contact information to amdm_secretary@att.net. Jobs will be published on this page within 48 hours and a notice sent to the AMDM membership alerting them to the new posting.
Posted 4.25.21
Spec, Regulatory Affairs - Sr- San Juan Capistrano, California - Monday to Friday
JOB SUMMARY:
Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling, advertising, and product withdrawals and recalls. Provide pre-market and post-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives. Supports applicable regulations including Local, State, Federal and/or International requirements.
JOB RESPONSIBILITIES
• Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling.
• Review and edit product submissions and other communications prepared by junior department members.
• Act as regulatory subject matter expert for junior department members.
• Provide pre-market and post-market regulatory strategy to ensure regulatory compliance and advance commercial objectives.
• Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.
• Independently communicate with regulatory agencies on pre-market and post-market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Provide back up to the Regulatory Affairs Director as needed.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES
Provide technical and editorial direction to junior department members.
JOB REQUIREMENTS:
EDUCATION and/or EXPERIENCE
BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required. Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards. At least five years of pre-market regulatory experience in IVD industry. Clinical research experience desired, but not required. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently. Must demonstrate leadership skills without having direct authority. Must have experience working on project/product from concept to market introduction. Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends. Must have experience in negotiation of technical issues with internal and external functions including health authorities.
LANGUAGE SKILLS
Must be detailed oriented. Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations. Requires ability to speak effectively before groups of customers or employees of organization. Requires the ability of organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms. Requires ability to understand and interpret regulatory requirements and technical standards. Must have the ability to write and organize complex reports and correspondence to regulatory agencies. Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations. Requires ability to edit and proof documents with detailed accuracy. Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
MATHEMATICAL SKILLS
Must have analytical reasoning and problem solving ability. Must be able to analyze quantitative information. Must have experience working with moderate to complex statistical techniques. Must have ability to calculate dilutions, titrations, and other laboratory methodologies. Must be skilled in basic algebra and geometry. Must be able to perform unit conversions. Must be able to tabulate random data and translate data into text conclusions.
REASONING ABILITY
Must have the ability to define problems, collect data, establish facts, and draw valid conclusions. Must have the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Must use logical thought processes and deductive reasoning. Must have the ability to apply rational sense to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several variables in non-standardized situations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. . Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work, general instructions on new assignments. Attention to detail. Must demonstrate the ability to get results despite a large workload, competing demands in a fast paced environment. Must have the ability to understand and interpret regulatory requirements and technical standards. Must possess the ability to identify issues and initiative to recommend solutions. Must have the ability to understand and translate implications of regulatory requirements on company policies and strategies.
CERTIFICATES, LICENSES, REGISTRATIONS
US-RAC preferred but not required.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit, hear, and use hands to finger, handle, or feel, and reach with hands and arms. The employee is also occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. The employee must be able to see up close, color, and have distance vision.
WORK ENVIRONMENT
The noise level in the work environment is usually moderate.
OSHA RISK CATEGORY
Category II - May encounter potential exposure.
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patients come first and that values do matter. We work to earn our customers’ trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. We have a large recognized brand; we offer flexibility and autonomy, great support, pay and benefits and a comprehensive training and onboarding program. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity / Citizenship
Click here to access the official listing and apply
Spec, Regulatory Affairs - Sr- San Juan Capistrano, California - Monday to Friday
JOB SUMMARY:
Provide regulatory guidance in product design, clinical studies, market authorization strategies, labeling, advertising, and product withdrawals and recalls. Provide pre-market and post-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives. Supports applicable regulations including Local, State, Federal and/or International requirements.
JOB RESPONSIBILITIES
• Provide regulatory guidance in product design, clinical studies, market authorization strategies, and labeling.
• Review and edit product submissions and other communications prepared by junior department members.
• Act as regulatory subject matter expert for junior department members.
• Provide pre-market and post-market regulatory strategy to ensure regulatory compliance and advance commercial objectives.
• Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.
• Independently communicate with regulatory agencies on pre-market and post-market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Provide back up to the Regulatory Affairs Director as needed.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.
SUPERVISORY RESPONSIBILITIES
Provide technical and editorial direction to junior department members.
JOB REQUIREMENTS:
EDUCATION and/or EXPERIENCE
BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required. Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards. At least five years of pre-market regulatory experience in IVD industry. Clinical research experience desired, but not required. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently. Must demonstrate leadership skills without having direct authority. Must have experience working on project/product from concept to market introduction. Must have proven analytical capabilities, solid understanding of manufacturing and change control, and awareness of regulatory trends. Must have experience in negotiation of technical issues with internal and external functions including health authorities.
LANGUAGE SKILLS
Must be detailed oriented. Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations. Requires ability to speak effectively before groups of customers or employees of organization. Requires the ability of organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms. Requires ability to understand and interpret regulatory requirements and technical standards. Must have the ability to write and organize complex reports and correspondence to regulatory agencies. Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations. Requires ability to edit and proof documents with detailed accuracy. Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
MATHEMATICAL SKILLS
Must have analytical reasoning and problem solving ability. Must be able to analyze quantitative information. Must have experience working with moderate to complex statistical techniques. Must have ability to calculate dilutions, titrations, and other laboratory methodologies. Must be skilled in basic algebra and geometry. Must be able to perform unit conversions. Must be able to tabulate random data and translate data into text conclusions.
REASONING ABILITY
Must have the ability to define problems, collect data, establish facts, and draw valid conclusions. Must have the ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Must use logical thought processes and deductive reasoning. Must have the ability to apply rational sense to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several variables in non-standardized situations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. . Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Receives no instructions on routine work, general instructions on new assignments. Attention to detail. Must demonstrate the ability to get results despite a large workload, competing demands in a fast paced environment. Must have the ability to understand and interpret regulatory requirements and technical standards. Must possess the ability to identify issues and initiative to recommend solutions. Must have the ability to understand and translate implications of regulatory requirements on company policies and strategies.
CERTIFICATES, LICENSES, REGISTRATIONS
US-RAC preferred but not required.
PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit, hear, and use hands to finger, handle, or feel, and reach with hands and arms. The employee is also occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. The employee must be able to see up close, color, and have distance vision.
WORK ENVIRONMENT
The noise level in the work environment is usually moderate.
OSHA RISK CATEGORY
Category II - May encounter potential exposure.
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patients come first and that values do matter. We work to earn our customers’ trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. We have a large recognized brand; we offer flexibility and autonomy, great support, pay and benefits and a comprehensive training and onboarding program. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity / Citizenship
Click here to access the official listing and apply
Posted 4.25.21
Spec, Regulatory Affairs II- San Juan Capistrano, California - Monday to Friday
JOB SUMMARY:
With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities, Notified Bodies and other regulatory agencies on defined matters to achieve approval to sell Celera products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.
IMPACT:
Successful performance contributes to the receipt of and maintenance of regulatory approvals to sell Celera products throughout the world.
JOB RESPONSIBILITIES:
1. Participate on project teams as regulatory or as RA/QA/CA representative.
2. Develop plans to receive approvals to sell products identified in the marketing sales plan.
3. Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
4. Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.
5. Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.
6. Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
7. Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.
JOB REQUIREMENTS:
- To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or CONFIDENTIAL AND PROPRIETARY INFORMATION.
EDUCATION AND/OR EXPERIENCE:
- Requires knowledge and skills normally acquired through the successful completion of a B.S. or M.S. degree in a scientific discipline or equivalent with a minimum of 5 years experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVD experience required. Experience with IVD PMA submissions preferred.
LANGUAGE SKILLS:
- Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.
MATHEMATICAL SKILLS:
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
REASONING ABILITY:
- Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to handle multiple projects and prioritize tasks/deliverables. Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form.
LICENSES, CERTIFICATES, REGISTRATION:
- Regulatory Accreditation Certificate desirable.
OTHER KNOWLEDGE, SKILLS AND ABILITIES:
Demonstrated working knowledge of submissions principles and good writing skills required.
POSITIONS SUPERVISED:
DIRECT: None
INDIRECT: Nonez
SUPERVISION RECEIVED:
Receives limited supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
INTERFACE WITH OTHERS:
INTERNAL:
Development, Materials, Manufacturing, Quality Control, Quality Assurance, Instrument Systems, Marketing and Technical Support organizations.
EXTERNAL:
Regulatory agencies, customers and marketing partners
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Most duties are performed while sitting at a desk, (i.e., operating a computer or typewriter, using a telephone, or writing and analyzing data and/or reports). Walking or standing within the office area may be required for the operation of other office equipment and for meetings.
WORKING ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier and telephone. The noise level in the work environment is usually moderate to quiet.
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patients come first and that values do matter. We work to earn our customers’ trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. We have a large recognized brand; we offer flexibility and autonomy, great support, pay and benefits and a comprehensive training and onboarding program. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity / Citizenship
Click here to access the official listing and apply
Spec, Regulatory Affairs II- San Juan Capistrano, California - Monday to Friday
JOB SUMMARY:
With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent Authorities, Notified Bodies and other regulatory agencies on defined matters to achieve approval to sell Celera products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.
IMPACT:
Successful performance contributes to the receipt of and maintenance of regulatory approvals to sell Celera products throughout the world.
JOB RESPONSIBILITIES:
1. Participate on project teams as regulatory or as RA/QA/CA representative.
2. Develop plans to receive approvals to sell products identified in the marketing sales plan.
3. Maintain knowledge and information of requirements to market products domestically and in all countries outside the U.S.
4. Timely preparation of regulatory submissions to the FDA, international dossiers/technical files required for CE Mark for EU countries and other international product registration files as required for ROW distribution.
5. Interacts with representatives from the Food and Drug Administration (FDA), Notified Body, Authorized Representative and other regulatory agencies to resolve issues or questions in the applications.
6. Maintain a library and knowledge of current standards and guidance documents as information reference for use by the organization.
7. Reviews product changes to determine if these changes affect product labeling and/or product registration/submissions.
JOB REQUIREMENTS:
- To perform this job successfully, an individual must be able to perform each essential job duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or CONFIDENTIAL AND PROPRIETARY INFORMATION.
EDUCATION AND/OR EXPERIENCE:
- Requires knowledge and skills normally acquired through the successful completion of a B.S. or M.S. degree in a scientific discipline or equivalent with a minimum of 5 years experience in a regulated industry. Three-four years regulatory submissions work in domestic/international registrations and IVD experience required. Experience with IVD PMA submissions preferred.
LANGUAGE SKILLS:
- Ability to read and analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from employees, managers, vendors or customers. Ability to effectively communicate plans, issues and resolve problems/conflicts in a project team setting.
MATHEMATICAL SKILLS:
- Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret graphs.
REASONING ABILITY:
- Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to handle multiple projects and prioritize tasks/deliverables. Ability to interpret a variety of instructions furnished in written oral, diagram, or schedule form.
LICENSES, CERTIFICATES, REGISTRATION:
- Regulatory Accreditation Certificate desirable.
OTHER KNOWLEDGE, SKILLS AND ABILITIES:
Demonstrated working knowledge of submissions principles and good writing skills required.
POSITIONS SUPERVISED:
DIRECT: None
INDIRECT: Nonez
SUPERVISION RECEIVED:
Receives limited supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
INTERFACE WITH OTHERS:
INTERNAL:
Development, Materials, Manufacturing, Quality Control, Quality Assurance, Instrument Systems, Marketing and Technical Support organizations.
EXTERNAL:
Regulatory agencies, customers and marketing partners
PHYSICAL REQUIREMENTS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Most duties are performed while sitting at a desk, (i.e., operating a computer or typewriter, using a telephone, or writing and analyzing data and/or reports). Walking or standing within the office area may be required for the operation of other office equipment and for meetings.
WORKING ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office environment utilizing standard office equipment such as a computer, photocopier and telephone. The noise level in the work environment is usually moderate to quiet.
Quest Diagnostics has many career opportunities for individuals whose talent, initiative and dedication will complement our belief that the patients come first and that values do matter. We work to earn our customers’ trust every day by providing the highest quality diagnostic information services in a professional, accessible and informative way. We have a large recognized brand; we offer flexibility and autonomy, great support, pay and benefits and a comprehensive training and onboarding program. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity / Citizenship
Click here to access the official listing and apply
Posted 3.11.21
Director, Regulatory Affairs Consultant, Precision for Medicine, Remote Position
In a landscape where dynamic change is the only constant, we help pharmaceutical and life science companies look beyond the boundaries of the present. We work as a team, spanning projects from molecule to medicine cabinet, anticipating incipient industry trends - then harnessing them. We are a global, mid-stage pharma and diagnostics services organization that is leading the industry in providing tailored solutions to diagnostic, biotech and pharma organizations whose focus is to develop and commercialize creative products in the new era of precision medicine. We have ~2,100 employees globally, and is led by a team of successful industry veterans. We understand that the route from assay development to commercialization is complex. Our comprehensive suite of solutions is designed to help our clients with novel or advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development, and over regulatory hurdles to regulatory approvals and market uptake. We focus on the end from the very beginning, cutting through clutter and helping our clients reach their goal faster. Our integrated team understands how the pieces fit together, and ensures that findings from each stage inform the rest of the process. In this role you will apply your extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.
How You Will Make an Impact:
Consulting Services
Qualifications:
Minimum Required:
https://boards.greenhouse.io/precisionmedicinegroup/jobs/4007672004
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Director, Regulatory Affairs Consultant, Precision for Medicine, Remote Position
In a landscape where dynamic change is the only constant, we help pharmaceutical and life science companies look beyond the boundaries of the present. We work as a team, spanning projects from molecule to medicine cabinet, anticipating incipient industry trends - then harnessing them. We are a global, mid-stage pharma and diagnostics services organization that is leading the industry in providing tailored solutions to diagnostic, biotech and pharma organizations whose focus is to develop and commercialize creative products in the new era of precision medicine. We have ~2,100 employees globally, and is led by a team of successful industry veterans. We understand that the route from assay development to commercialization is complex. Our comprehensive suite of solutions is designed to help our clients with novel or advanced in vitro, laboratory-developed, and companion diagnostics take the shortest path from test concept through clinical trial development, and over regulatory hurdles to regulatory approvals and market uptake. We focus on the end from the very beginning, cutting through clutter and helping our clients reach their goal faster. Our integrated team understands how the pieces fit together, and ensures that findings from each stage inform the rest of the process. In this role you will apply your extensive expertise and in-depth knowledge of the regulatory affairs, quality systems and marketing authorization process for small and large pharma and life science companies to develop actionable business solutions.
How You Will Make an Impact:
Consulting Services
- You will lead the preparation of in vitro diagnostic submissions and design strategic approaches to regulatory approvals, clearances, and post-market requirements to reflect the optimal business solutions for clients.
- You will review and lead the development of analytical and clinical protocols, technical reports and other documents for use in regulatory submissions and in response to queries from regulatory agencies.
- You will collaborate with external thought-leaders and technical experts to support research and development, regulatory authorization, and marketing
- You will provide program essential tools such as project plans, communication plans, etc.
- You will inspect regulatory communication, submission, timeline and approval requirement documents
- You will apply quality systems expertise to guide clients towards successful readiness to market products in a regulated environment
- You will generate new business through your own network
- You will work with the management team to design and develop customized, program recommendations and preliminary strategies for inclusion in client proposals
- You will lead workshops and conference curriculums in the areas of translational and regulatory science for in vitro diagnostics
- You will partner with the business development team to support the evaluation of requests for proposals and consider regulatory strategies that can be used and regulatory approval timelines
- You will work with the business development team with client bid defense meetings by communicating the key regulatory considerations of the program to the project team and assisting with the development of the presentation materials for these meetings
- You will be a regulatory compliance subject matter expert who can speak to the strategic positioning and considerations of the program within the healthcare marketplace and who can discuss the established precedents from other similar programs
- You will identify client needs and develop solutions by gaining an understanding of the client’s product, the brand objectives and other relevant industry trends
- You will stay abreast of the latest regulatory and scientific developments in the marketplace that will impact the line of business by identifying market trends, new ways of thinking, etc.
Qualifications:
Minimum Required:
- Bachelor’s degree in Life Sciences or equivalent work experience
- Minimum 5 years of applicable consulting experience with a focus in regulatory affairs
- Minimum of 7 years of experience working in a IVD, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment
- Strong written and verbal communication skills
- Strong leadership, team building and interpersonal skills
- Strong business and financial acumen
- Strong scientific and analytical skills
- Ability to think outside of the box and solve hard problems with effective solutions
- Direct experience working with small and large companies to design global regulatory and commercialization strategies
- Experience managing staff members and project teams
https://boards.greenhouse.io/precisionmedicinegroup/jobs/4007672004
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Posted 2.11.21
Vice President, Quality and Regulatory Affairs, Inova Diagnostics, San Diego, CA
About Inova Diagnostics:
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
Position Summary:
Reporting into the Chief Executive Officer, the Vice President of Quality and Regulatory Affairs is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance (PPRC per IVDR) and HIPAA Privacy Officer. Provides leadership and development to assigned teams and staff. Serves as a member of Inova’s Executive Committee.
Key Accountabilities
This position is located in San Diego, CA and will require occasional travel.
Inova provides an attractive compensation and benefits package Including:
Company paid for employee:
Medical
Dental
Vision
Life Insurance
401K with a company match
Paid time off
To Apply: Send resume to ksmith@inovadx.com
COVID-19 Precaution(s):
Notice to Agency and Search Firm Representatives: Inova Diagnostics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Inova employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Inova. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you
Inova Diagnostics, Inc. Appreciates and Values Diversity.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Vice President, Quality and Regulatory Affairs, Inova Diagnostics, San Diego, CA
About Inova Diagnostics:
Inova Diagnostics is a privately held company headquartered in San Diego, California, and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers. Further information about Inova Diagnostics can be found at www.inovadx.com.
Position Summary:
Reporting into the Chief Executive Officer, the Vice President of Quality and Regulatory Affairs is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products. Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance (PPRC per IVDR) and HIPAA Privacy Officer. Provides leadership and development to assigned teams and staff. Serves as a member of Inova’s Executive Committee.
Key Accountabilities
- Establishes, implements, and manages the overall regulatory affairs, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all company products. This includes monitoring the complete manufacturing and QA/QC process to ensure conformance and compliance, as well as management of the Quality System, ensuring compliance with applicable local and international regulatory requirements and/or programs including but not limited to the regulatory requirements of the U.S., Canada and other MDSAP countries, ISO 13485, IVDD, IVDR, FDA and c-GMP guidelines and HIPAA regulations.
- As a member of the senior management team, provides sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
- Continuously identifies opportunities to improve the Quality System, product quality, simplify processes and/or reduce of the costs of quality.
- Manages the quality and regulatory staff and departmental resource needs.
- Provides leadership and management to ensure that the mission and core values of the company are put into place.
- Creates and leads a high-performing, innovative, management team that attracts, recruits, develops and retains exceptional staff.
- Reflect the values of Werfen and Inova as a role model to employees, customers, and business partners.
- Werfen People Manager competencies: Building talent, Driving for results, Customer focus, Driving for innovation, Emotional intelligence.
- Strategic thinking
- Leadership, coaching and mentoring
- Communication and influence
- Business acumen
- Financial management
- Technical Capacity
- Analysis and problem solving
- Education: Bachelor’s degree in life sciences or related field required; advanced degree or certification in Quality or Regulatory preferred.
- Experience: 10 plus years of experience in the medical device industry, including management experience required.
- Skills & Knowledge:
- Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required.
- Excellent knowledge of Quality Systems Regulations, IVDR and ISO regulations as they apply to device manufacturing required.
- Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required.
- Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required.
- Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required.
- Track record of success at building and leading high performing, complex teams.
This position is located in San Diego, CA and will require occasional travel.
Inova provides an attractive compensation and benefits package Including:
Company paid for employee:
Medical
Dental
Vision
Life Insurance
401K with a company match
Paid time off
To Apply: Send resume to ksmith@inovadx.com
COVID-19 Precaution(s):
- Remote interview process
- Personal protective equipment provided or required
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place
Notice to Agency and Search Firm Representatives: Inova Diagnostics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Inova employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Inova. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you
Inova Diagnostics, Inc. Appreciates and Values Diversity.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.