Jobs - ASSOCIATION OF MEDICAL DIAGNOSTICS MANUFACTURERS

Job Postings

AMDM posts open positions within the IVD Industry.

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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 10.30.19
Position Title: Director – Regulatory Affairs, Goldbug Strategies

Job Summary
Director, Regulatory Affairs is responsible for providing Regulatory support to Goldbug Strategies’ clients. This position will provide strategic and tactical support to Goldbug’s internal team and clients. This position is responsible for assisting in defining and executing the regulatory strategy and project plan, researching precedents, and developing content for all deliverables in the Project Regulatory Plan, as appropriate, including regulatory submissions. In addition, they will ensure adherence to established processes, policies and procedures of the company and clients (as required).

Responsibilities

Responsible and accountable for defining and executing regulatory strategy, researching precedents, providing regulatory guidance and support to Goldbug’s internal team and client’s product development teams throughout the Total Product Life Cycle (TPLC).
Authors, reviews, edits, coordinates, assembles, and prepares submission documents to FDA, including Q-Sub documents, PMA and/or De Novo 510(k) submissions, and the respective supplements and/or amendments to the above submissions, post-marketing supplements, etc.
Engages regulators, when necessary, in verbal and written communications to discuss pending or new submissions, regulatory requirements, address questions, etc.

Embraces being a Regulatory subject matter expert with an external focus on regulatory intelligence, proactively and constantly keeping current in regard to US regulations, guidance documents, Federal Register notices, etc., and competitor news – across all aspects of the TPLC in the technology and therapeutic focus areas of Goldbug Strategies’ business.

Conduct training and/or proactively share effectively and efficiently any appropriate news, resource materials, etc., so as to build Goldbug’s knowledge base.
Effectively apply regulatory intelligence and knowledge gained through research and review of precedents across Goldbug clients to enrich regulatory strategies and/or internal processes applied to clients.
Participate in business meetings with existing and prospective clients, as appropriate.

Experience/Education

Minimum of 8 years of Regulatory Affairs experience in In Vitro Diagnostics. Experience must include De Novo and/or PMA Submissions.
- Demonstrated experience in multiple aspects of Regulatory Affairs throughout the TPLC including regulatory pathway/strategy development, analytical and clinical validation requirements, design control, Quality Systems, post-marketing requirements, etc.
Experience representing Regulatory on project teams providing proactive and successful regulatory advice and strategy.
Successful experience in effective communication between companies and Regulatory Agencies.
Minimum requirement of a bachelor’s degree in life sciences, bio-engineering or related science. Advanced degree (MS or PhD) in life sciences preferred.

Skills and Qualifications

Overall positive “can-do” attitude and service-minded approach.
Excellent written and verbal communication skills, including presentation and technical writing skills. Demonstrated ability to communicate clearly, succinctly, and effectively in person, over the phone, and in writing. Comfortable communicating with executive management/leaders.
Strong interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
Ability to work as a member of a team in a timeline-driven environment with limited supervision.
Must be self-driven, capable of operating autonomously.
Must possess strong organizational skills. Detail-oriented yet can see the “big picture”; able to handle multiple projects concurrently.

To apply for this position, send a cover letter and resume to wendy@goldbugstrategies.com

Posted 10.9.19
Position Title: Dir of Regulatory Affairs - CDx, Guardant Health
Department: Regulatory Affairs
Position Summary:
The Dir of Regulatory Affairs provides direct regulatory support for CDx. This role supports development and implementation of regulatory strategy for CDx including IDE programs, IVD, and companion diagnostics. In this role you will support program efforts relative to premarket submissions, diagnostic partnering with biopharma, FDA interface regulatory policy and practice. Facilitate integration of Dx regulatory strategy at Guardant Health. This role, as an individual contributor, will report to the VP of Regulatory affairs and will liaise closely with the current regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to patients.

Essential Duties and Responsibilities:

Ensure early diagnostic regulatory input in early stages and during clinical development to Development Team for CDx.
Oversee regulatory compliance and the action roadmap for activities with the FDA and EU and other regulatory bodies to ensure Guardant Health’s interests are reflected.
Collaborate closely with pharma partner regulatory affairs for all companion diagnostic programs.
Provide input for all Business Development activities with respect to the regulatory risks and benefits of potential deals.
Provide training for key stakeholders
Represent the regulatory function with objective advocacy of the projects pipeline potential as well as the overall regulatory perspective in diagnostic regulatory requirements
Ensure alignment of regulatory strategy to business strategy across all functional areas
Manage development and negotiation of plans regarding safety, efficacy, and quality to assure viability for US and other global registrations.
Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements.
Working with VP, Regulatory Affairs, identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other International Quality Standards as appropriate. This includes, but is not limited to, country specific licenses, the design input, review, out-put and verification, validation, transfer and change control.
Provide updates as needed to the VP RA regarding regulatory status and requirements, both U.S. and European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC.
Compile and/or direct the compilation of device master records, technical files, design dossiers, FDA and European submission documents, and/or any other relate documents/reports, ensuring timely submissions to CDRH, etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.
Responsibility for MDR reporting and assessments of adverse event reports to determine if reportable. Provide regulatory support as required in the evaluation of customer complaints, ensuring complaint reports meet regulatory requirements.
Write and maintain procedures relating to the US and International Regulatory requirements.
Champion the design, development and implementation and then support management, and maintenance of the Company’s Quality System to meet the requirements of US FDA (21CFR 820 QSR, 21CFR 600 and 21 CFR 211), EN 13485, ISO 13485, IVDD and all other applicable quality and regulatory standards.
Responsibility for ensuring Post Market surveillance/ vigilance systems, liaising with others in the quality departments, QA/QC.
Complete other tasks as assigned by the VP, RA.

Qualifications:

Advanced education degree in life-sciences, engineering or public health with more than 5 years work related profession experience. Or a Bachelor’s degree in similar fields with 8 plus years of experience.
3+ years experience in drug or diagnostic regulatory affairs.
5+ years multi/cross functional experience in regulatory and/or clinical development, preferably in molecular diagnostics
Knowledge of IVDs or drug development and regulation affairs requirements
Familiar with regulatory issues and challenges associated with Drug/Diagnostic co-development and companion diagnostics.
Track record in successful FDA and ROW premarket submissions and registrations
Solid understanding of molecular technologies and the impact on outcomes and diagnostic results
Leadership capabilities working across varied cultures, expertise and backgrounds
Excellent negotiation skills on various levels of hierarchy
Outstanding interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective collaboration.

Click Here to Apply

Posted 10.9.19
Clinical Affairs Project Manager – Cardiac Focus, Siemens Healthineers, Point of Care
Job ID: 180512
Location: US - Massachusetts – Norwood (Edgewater)

Position Overview
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for an experienced clinical operations leader to join our enthusiastic and collaborative team.

The selected senior professional will:

Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development
Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality
Report to Director, Clinical Affairs, Quality, Point of Care Business Area

Responsibilities

Managing clinical studies, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management
Conducting and/or assisting clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols
Monitoring conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need
Assisting clinical sites with IRB submission/documentation, as needed
Preparing the clinical portion of Pre-Subs, 510ks and other regulatory submissions
Proactively anticipating and identifying issues; implementing solutions, proposing corrective actions in areas relevant to the role
Cross-functionally assisting other Quality colleagues, Regulatory Affairs and Quality Systems, as workload permits to support efforts in these areas

Required Knowledge/Skills, Education, and Experience

BS/BA in life science discipline or equivalent combination of education and experience; Medical Technologist or similar (MT/MLT) highly preferred
Demonstration of 8-10 years of deep professional know-how and successful experience in related field; evidence of successful performance of responsibilities presented above
CCRA certification with ACRP or SoCRA
Experience with in vitro diagnostics and/or medical device industry
Experience conducting cardiac-focused clinical studies
Experience with Pre-Subs and 510k submissions
Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical study reports, etc.)
Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels

Ability and willingness to travel, depending upon project need (occasionally up to 40% domestically; <20% internationally)

Interested candidates’ CVs should be directed to Erika Moccia at erika.moccia@siemens-healthineers.com

Posted 10.8.19
Sr. Director, Global Strategic Regulatory & Clinical Affairs, Thermo Fisher Scientific

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Job ID : 100162BR
Location : US - Massachusetts - Waltham

Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?
The Director of Global Strategic Regulatory and Clinical Affairs will be responsible for providing corporate regulatory and clinical leadership and expertise to drive alignment and harmonization of global regulatory and clinical policies across Thermo Fisher Scientific’s Groups and Divisions. The position will utilize regulatory and clinical intelligence to create and maintain corporate policies and develop strategic practices to address regulation and legislative changes for global regulatory and clinical compliance. The incumbent will be part of the Thermo Fisher Scientific Corporate Quality and Regulatory team based in the U.S. and will serve as an active leader of Regulatory and Clinical Affairs within the Global Quality and Regulatory Council. This role will manage the global Corporate Regulatory and Clinical resources to establish the necessary QARA network between Divisions, their sites and global regulatory organizations and authorities.

What will you do?

Establish and Chair the Company’s Regulatory and Clinical Affairs Council
Work efficiently with cross-divisional functions and businesses to drive corporate regulatory and clinical business objectives.
Be responsible for the corporate policy Controlling External Regulatory and Clinical standards.
Pro-actively evaluate and interpret relevant global regulations, guidelines and evolving regulatory trends which impact Company products and services.
Maintain up-to-date knowledge of international and domestic regulatory and clinical requirements encompassing research, medical device, IVD and pharmaceutical products.
Assure effective communication and execution of corporate policies.
Provide strategic regulatory and clinical leadership driving corporate initiatives, determining risk and impact based on intelligence across mature and immature markets.
Serve as the corporate interface with external organizations, participating in public meetings, industry conferences and workshops applicable to the Company’s regulatory agenda.
Foster collaborative relationships with corporate partners.
Identify opportunities to strengthen the efficiency and effectiveness of regional and global regulatory and clinical affairs teams/organizations.
Lead cross-divisional internal regulatory expert/working groups in order to further develop regulatory competencies within the company.

Education

Bachelor’s degree or equivalent in STEM technical subject matter (e.g. chemistry, biochemistry, biology, etc.)

Experience

A minimum of 15 years professional regulatory experience with competency in the areas of medical device, pharmaceutical, research and in vitro diagnostic products

Knowledge, Skills, Abilities

Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance
Ability to work independently, taking responsibility for the management of processes, projects and timelines
Ability to influence and lead change across Groups and Divisions to implement new programs, policies and processes
Ability to author standard operating procedures and company policies
Ability to drive results in a matrix organization, especially having representatives from different cultures come together, embracing diversity
Strong demonstration of leadership capabilities with experience in leading programs and projects

Travel Requirement

25-40% regional and international travel is expected

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Click Here to Apply

Posted 10.8.19
Director, Corporate Surveillance/Principal Auditor, Thermo Fisher Scientific
Job ID : 96156BR
Location : US - Massachusetts - Waltham

Job Description
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

How will you make an impact?
The Director, Corporate Surveillance/Principal Auditor is responsible for ensuring compliance to global governmental regulatory requirements, corporate policies, group and divisional processes and site level procedures. The goal of the program is to identify and highlight compliance gaps for management so that appropriate and timely action can be taken to reduce the overall risk to the company. The program accomplishes this through a methodical, collaborative and organized process driven by exceptionally qualified staff. The Corporate Audit Program focuses on all operations (manufacturing, logistics and commercial) that could impact Thermo Fisher Scientific’s brand, market reputation, patients, consumers and customers.

What will you do?
The role is accountable for ensuring the Company’s corporate quality audit program provides an accurate ongoing assessment of the Organization’s compliance profile across all its sites and operations including measuring compliance risk and assessing remediation needs and improvement opportunities across the enterprise. The incumbent requires significant business auditing experience as well as recent experience working with FDA and other global competent authorities.
Under her/his leadership, the Quality Audit organization examines operational and compliance activities while building an audit program with a risk-based schedule to drive execution of internal quality audits. The Quality Audit team is responsible for performing unbiased assessments and reports its findings and recommendations to senior management, thereby addressing the strength of internal control systems, enhancing the cost effectiveness and efficiency of operations and maintaining proper accountability for compliance while managing risks appropriately.

Education

Bachelor of Science Degree/STEM required. Master’s Degree preferred (not MBA)

Experience

> 10 years IVD/Med Device/Pharma Industry experience required
Practical experience building and sustaining quality systems required
>/= 5 years former FDA ORA employment required
>15 years’ total experience (minimum 5 in a leadership role) in the life sciences/healthcare industries
Recognized expert with a proven track record of 8 or more years managing and delivering best practices in the quality assurance field including Quality Audit services in large, complex, global organizations
Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices/pharma/IVD partnering with functional stakeholders and experts

Knowledge, Skills, Abilities

Knowledge of FDA GxP, 21 CFR Part 820, 803, 806, 210, 211 QSR, ISO 13485, ISO 9001 and global regulatory standards required (China, Brazil, EU)
Software auditing experience preferred
Familiarity with compliance IT systems such as TrackWise or MasterControl
Excellent problem-solving and analytical skills
Ability to interface with technical resources and scientifically based teams
Strong technical writing experience required (English)

Required Knowledge, Skills, Abilities

Adherence to our organizational values of Integrity, intensity, Innovation and Involvement
Ability to travel up to 60% of the time

Posted 10.1.19
JOB TITLE: Regulatory Associate, Astute Medical, Inc.
DEPARTMENT:         Regulatory Affairs
REPORTS TO:           Vice President Clinical & Regulatory Strategy

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Regulatory Associate.

JOB SUMMARY:
This position will work as part of the Regulatory Department with direct responsibility for maintaining regulatory department documentation which includes updating, cataloging, archiving and processing department documents (e.g., regulatory submissions – 510(k)s, PMAs; technical files; etc; permits and licenses; regulations, guidance documents, and quality system procedures; post-market, adverse event/recall documentation; publications/bibliographies – clinical/scientific literature, periodicals; communications; product registration matrix; department training, etc. The successful candidate will assist in the preparation and maintenance of documentation for international and domestic product registrations, permits and licenses which may include responsibilities for compiling documents for medical device applications/technical files, public notary, etc. Assists in processing of change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc. Participates on internal/external project teams (i.e. design control, change control, CAPA, complaints) involving regulatory review, approval and feedback. May participate in internal/external audits. May interact with regulatory agencies with respect to facility inspections, licensures and permits. Ensures regulatory compliance with QSR (21 CFR Part 820), ISO13485, IVDD/IVDR, corporate policies/procedures and other state, federal and worldwide regulatory requirements as appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Aids in the preparation of regulatory documentation for domestic and international product registrations and secures appropriate regulatory documentation including device licenses, device listings, permits and import/export certificates.
Interfaces with domestic and international partners/distributors regarding registrations and licenses.
Researches and aids in the interpretation of FDA, IVDD/IVDR, etc regulations.
Interacts with product/project teams to provide regulatory guidance with respect to product development and change control processes and may be responsible for the preparation and review of associated deliverables.
Works with product/project teams on compiling risk assessment.
Ensures product technical files, documentation and relevant clinical/scientific literature are maintained and periodically updated as required to maintain a state of audit/inspection-readiness
Generates/revises documentation and data necessary for department operations (e.g., SOPs, forms, tables, records, reports, meeting summaries, etc.)
Advises/acts on implications of new or amended standards relevant to medical devices manufactured by Astute Medical.
Aids in the evaluation of customer complaints for regulatory compliance and adherence to product claims.
Plans and participates in internal and external audits as required.
Travels to audits, industry conferences/meetings or external training events may occur as required.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
A minimum of scientific degree (BS) and experience in IVD regulatory affairs typically acquired through 3-5 years relevant industry experience; or equivalent plus knowledge the length of which is dependent on the level of qualifications achieved.
Basic knowledge of relevant Quality System Standards (21 CFR Part 820, ISO 13485, etc.) in an IVD/Medical Device manufacturing environment.
General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
Ability to work cohesively with multi-disciplinary scientific working groups.
Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
Proficient with Microsoft Office suite.

PHYSICAL DEMANDS:
While performing the duties the employee is:

Constantly required to reach computers and other office equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Frequently required to sit
Frequently required to stand
Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
Frequently required to lift and transport items weighing up to 25 lbs.
May occasionally be required to travel to audits, meetings, tradeshows

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.

Apply at: https://recruitment.biomerieux.com/careersection/2/jobdetail.ftl?job=57041&tz=GMT-04%3A00&tzname

Posted 10.1.19
JOB TITLE: Senior Regulatory Affairs Specialist, Astute Medical, Inc.
DEPARTMENT:         Regulatory Affairs
REPORTS TO:           Vice President Clinical & Regulatory Strategy

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the development and commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Senior Regulatory Affairs Specialist.

JOB SUMMARY:
This position will provide support to the Vice President, Clinical & Regulatory Strategy in the implementation of global regulatory strategies for marketed and development products. This individual will lead or support regulatory activities for internal and external programs and will work closely with cross-functional subject matter experts to ensure an effective partnership and execution of regulatory strategy, regulatory requirements, and the timely submission and approval of global regulatory filings.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Support management with development and implementation of departmental strategies and policies.
Manage, coordinate and review regulatory submission/registration documentation for domestic and international product registrations, including the Independent determination of the necessary design documentation (including language/labeling requirements).
Interpret regulations and provide regulatory guidance and strategy to cross functions project teams.
Develop gap and impact assessments of changing global regulatory requirements (e.g., IVDR) and revise or drafts new documentation accordingly.
Compile and maintain regulatory database of regulatory information, labeling and change requirements for international registrations to support market expansion.
Regulatory lead on product/project teams, providing regulatory guidance with respect to product development and design control (changes and processes) and responsible for the preparation and review of associated deliverables.
Independently research, prepare, and present on global regulatory topics to internal and external stakeholders. Contribute to the development and implementation of regulatory strategy to mitigate risks.
Assure compliance with all applicable (domestic and international) regulations.
Monitor regulatory trends and be able to apply learnings and provide guidance or strategy related to such trends.
Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
May mentor or lead other department staff.
Other duties as assigned.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

Degree in a relevant field (BS/MS in engineering or science ideal) with 4-6 years relevant MD/IVD regulatory affairs experience (or equivalent combination education and/or work experience in another function with demonstrated transferable skills set dependent on the level of qualifications achieve.
IVD, clinical diagnostic, CLIA or similar experience is preferred.
General working knowledge of current and evolving state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, CMDR, and other worldwide regulatory regulations as appropriate and standards, e.g., ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
Prior direct interactions with Health Authorities is desirable.
Highly self-motivated; works on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
Exceptional writing skills and verbal interpersonal skills to influence many diverse internal/external customer groups.
High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
Ability to work cohesively with multi-disciplinary scientific working groups.
Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio.

PHYSICAL DEMANDS:
While performing the duties the employee is:

Constantly required to reach computers and other office equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Frequently required to sit
Frequently required to stand
Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
Frequently required to lift and transport items weighing up to 25 lbs.
May occasionally be required to travel to audits, meetings, tradeshows

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.

Apply at: https://recruitment.biomerieux.com/careersection/2/jobdetail.ftl?job=56990&tz=GMT-04%3A00&tzname

Posted 10.1.19
JOB TITLE: Senior Quality Assurance Engineer, Astute Medical, Inc.
DEPARTMENT:         Quality Assurance
REPORTS TO:           Senior Director, Quality Assurance

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the life-cycle of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Senior Quality Engineer.

JOB SUMMARY:
Astute Medical, Inc. is seeking a Senior Quality Engineer who will be responsible for ensuring Astute Medical establishes and maintains compliance to ISO13485, ISO14971, 21CFR Part 820, the IVDD, the IVDR and other applicable regulations and standards. Emphasis is placed on strong understanding and experience with applicable ISO/EN standards, FDA, QSR, and European IVDD/IVDR as well as experience with ISO and/or FDA audits.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsible for ensuring compliance with applicable Astute Medical policies and procedures across the organization.
Refine Quality System procedures and processes based on knowledge of regulations and business needs as well as output from the CAPA system.
Assess Quality System for impact of new standards including IVDR.
Facilitate cross-functional team meetings for collaboration on design change plans, risk management, manufacturing change requests, and internal audit findings.
Lead and facilitate FMEA meetings with applicable functional areas to assess and update risk documents for process changes, design changes, complaints, CAPA, etc. Write risk reports and conduct post-market surveillance on product lines in compliance with current requirements for ISO14971.
Establish statistically based sampling plans for variable and attribute data for validations, CAPAs and contract manufacturing testing. Mentor and provide guidance to others on statistical based plans.
QA lead in validation strategy meetings (software, equipment, and process). Advise team on required acceptance criteria, develop statistically based sampling plans. QA lead on discrepancy resolution. Review and approve validations.
Conduct all aspects of supplier and internal audits. Develop and write audit plans, conduct audit, write audit reports. Collaborate with audit team and auditees on findings and corrective actions.
Facilitate continuous improvement of the CAPA system including CAPA metrics. Lead and provide direction on investigations and corrective/preventive actions related to issues received through CAPA, post market surveillance, and product support as required to determine deficiencies in the quality system, product and manufacturing processes.
Quality lead for NephroCheck Test System. Review Design Change Plans for assessment of impact to areas of Design Control (e.g., Design Input Requirements, verification, validation, requirement outputs). Lead bi-weekly design change meetings. Ensure Design Change are compliant with internal and external regulations. Responsible for ensuring all DHF documentation is present and maintained.
Mentor other members of Quality team and cross-functional teams.
Performs other duties & projects as assigned.
Identifies and addresses all complexities of compliance issues

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

BS/BA (or higher) degree in science/technical discipline or equivalent.
5+ years related experience or equivalent.
Strong emphasis placed on working with technical disciplines and understanding of product technologies and associated processes.
Strong experience with federal, 3rd party agencies or regulatory agencies, e.g., 21 CFR Part 820, ISO14971, ISO 13485, IVDD and IVDR.
Knowledge and application of statistical techniques.
Ability to work on multidisciplinary teams.
Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
Problem-solving and troubleshooting skills.
Strong verbal and written communication skills.

Demonstrates time management, decision making, presentation, and organization skills required.
Proficient with Microsoft Office and Visio.
Willing and able to travel as required (~10-25%)

PHYSICAL DEMANDS:
While performing the duties the employee is:

Constantly required to reach computers and other office and laboratory equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Frequently required to sit
Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
May occasionally be required to travel to meetings and tradeshows

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary

Apply at: https://recruitment.biomerieux.com/careersection/2/jobdetail.ftl?job=55607&tz=GMT-04%3A00&tzname

Posted 10.1.19
JOB TITLE: Senior Director, Quality Assurance, Astute Medical, Inc.
DEPARTMENT:         Quality
REPORTS TO:           Vice President Clinical & Regulatory Strategy

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, experienced, and self-motivated individual for the position of Senior Director, Quality Assurance.

JOB SUMMARY:
Reporting to the Vice President Clinical & Regulatory Strategy, Senior Director of Quality Assurance has primary accountability of all aspects of Astute's Quality efforts such as developing and administrating Astute's Quality Management System (QMS), training and coaching employees, and facilitating change throughout the organization. Responsible for establishing strategy, policies and procedures at all levels so quality improvement efforts will meet internal and external customers' needs and expectations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Lead Company's corporate Quality Assurance function, with direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of Astute's QMS;
Manage and monitor the QMS in accordance with applicable federal, state and international regulations (e.g., 21CFR820 and IVDR) and standards (e.g., ISO 13485, ISO 14971, GMP requirements) to ensure its continuing suitability, adequacy, and effectiveness, including assessments of opportunities for improvement and need for changes;
Keep abreast of the evolving regulatory policy and industry best practices related to in vitro diagnostics in the US and internationally, leading the evolution of Astute's QMS, as appropriate;
Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for Quality Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making;
Identify and suggest functional improvements to the Document Control and Quality Assurance organizations to further ensure regulatory compliance and constant inspection readiness;
Collaborate with functional areas to establish and update metrics that are reported to upper management that highlights risks and key opportunities for continuous quality improvement;
Provide Quality Assurance input on manufacturing, quality control, and product development processes to maintain compliance with the relevant quality regulations and international standards;
Provide Quality Assurance input and resources to author, review and finalize quality related documents for regulatory submissions globally, including 510(k) and CE-IVD;
Host FDA / third party regulatory inspections/audits, as needed, and ensure follow up on findings/observations issued including issuing CAPAs, as needed;
Ensure budgets, schedules, and department performance requirements are met;
Ensure Quality Assurance representation in all phases of IVD product development: concept, feasibility, design and development, verification and validation, manufacturing transfer, and commercialization - author quality plans and reports;
Ensure compliance with calibration and validation requirements for the facility;
Ensure compliance of Astute 's electronic document management system (EDMS, Master Control) with required regulations; including EDMS system implementation and maintenance, validation of changes to the system, and training of other employees;
Ensure compliance with Company's QMS and ensure that all individuals reporting to him/her comply with the Company's QMS;
Other duties as assigned.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

BS degree (or higher) in the physical sciences, life sciences, or engineering disciplines (physics, chemistry, chemical I biomedical engineering, biochemistry, or biology) or equivalent;
10+ years in medical device/ IVD field, with responsibility for a broad spectrum of Quality System elements and 4+ years management responsibility for QA personnel, preferred, however, other experience may be acceptable;
In-depth knowledge of and demonstrated experience with leading cross-functional teams through development, implementation, application, and maintenance of Quality Systems which comply with FDA QSR, GMP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery;
Successful track record of selecting, implementing, and optimizing electronic quality management system software including modules for document control, complaints, nonconformities, CAPA, and other Quality System functions;
Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity;
Experience developing and managing departmental operating and capital budgets;
Extremely detail-oriented with strong organizational skills and high quality standards;
Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change, and driving the adoption of new processes from a position of indirect or informal authority;
Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style;
Ability to integrate and apply feedback in a professional manner;
Holds self and others accountable for adherence to high work and ethical standards;
Ability to travel as required (up to 20% domestic and international), preferred;

PHYSICAL DEMANDS:
While performing the duties the employee is:

Constantly required to reach computers and other office and laboratory equipment
Constantly required to view objects at close and distant ranges
Frequently required to communicate with others
Frequently required to sit
Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
May occasionally be required to travel to meetings and audits

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:
Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.

Apply at https://recruitment.biomerieux.com/careersection/2/jobdetail.ftl?job=57305&tz=GMT-04%3A00&tzname