|
|
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 [email protected]. 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 [email protected]. 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 Date: 3/31/2023
Position Title: Regulatory Affairs Senior Specialist (738950), CD Diagnostics
Requisition Number AMER27567
Employment Type Full-time
Location Virtual Office - Indiana, Indiana
Job Summary
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
This position is for CD Diagnostics requires an advanced understanding of In-Vitro Diagnostic (IVD) and medical device products and their use as well as an understanding of the regulatory submissions process.
Principal Duties and Responsibilities
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
• Thorough working knowledge of all IVD digital health aspects of CE-Marked and FDA-regulated Class I and II medical devices.
• Preferably affinity and experience with the development of Software as a Medical Device (SaMD) in the digital health-based diagnostic / IVD arena.
• Working knowledge of FD&C Act and CLIA Waiver implementing regulations
• Demonstrate strong writing and communication skills
• Strong interpersonal skills and attention to detail
• Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
• Proficient knowledge of overall business environment, the orthopedic industry and the marketplace
• Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
• Able to identify risk in regulatory strategies
• Robust product knowledge
• Advanced anatomic knowledge
• Proven analytical and negotiation skills
• Experience with solving problems and concerns
• Intermediate computer skills, including Microsoft Office Suite
• Ability to lead a team and influence others
• Proficient knowledge of FDA and EU IVDR regulations (including labeling regulations) and regulations outside of the US/EU
Education/Experience Requirements
• US Bachelor’s Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
• Advanced degree preferred
• A minimum of 5-7 years of experience in Regulatory Affairs required
• A minimum of 2 years of experience in orthopaedic or in-vitro diagnostic device industry preferred
• Previous hands-on experience with the Regulatory processes behind the compilation of 510(k)s, Q submissions, CLIA Waiver highly preferred
• Regulatory Affairs Certification (US or EU) preferred
• A combination of education, experience, leadership, strategy and RA influence may be considered
Travel Requirements
Up to 15%
Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
To apply, please follow the links below.
https://www.zimmerbiomet.com/en/about-us/careers/job-details.477132.html
https://www.linkedin.com/jobs/view/regulatory-affairs-senior-specialist-738950-at-zimmer-biomet-3540956404/
Position Title: Regulatory Affairs Senior Specialist (738950), CD Diagnostics
Requisition Number AMER27567
Employment Type Full-time
Location Virtual Office - Indiana, Indiana
Job Summary
Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
This position is for CD Diagnostics requires an advanced understanding of In-Vitro Diagnostic (IVD) and medical device products and their use as well as an understanding of the regulatory submissions process.
Principal Duties and Responsibilities
- Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions which include Pre-Submissions, 510(k)s, IVDR submissions.
- Primary point of contact for in vitro diagnostic (IVD) and specimen collection kit-related matters, including assisting with product development, classification questions, regulatory submissions, if applicable, as well as reviewing label/labeling, advertisement, promotional, and other customer facing materials for compliance with FDA regulations and guidelines
- Advise on questions related to compliance with regulations related to IVDR, CLIA Waiver requirements.
- Acquires and maintains current knowledge of applicable regulatory requirements, including IVD regulations and scientific/technical principles
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates
- Researches, analyzes and communicates information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research
- Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
- Evaluates risk of proposed regulatory strategies and offers solutions
- Reviews proposed labeling for compliance with applicable US, EU and international regulations
- Writes, manages, and approves the development of package inserts and product labeling
- Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations
- Reviews proposed product changes for impact on regulatory status of the product
- Interprets and applies IVDR and FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
- Follows Zimmer Biomet regulatory affairs policy and procedures
- May provide training and/or guidance to entry-level associates, analysts, interns, and specialists
- Communicates with regulatory and governmental agencies and represents RA in IVDR and MDSAP audits
- Miscellaneous responsibilities as assigned
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
• Thorough working knowledge of all IVD digital health aspects of CE-Marked and FDA-regulated Class I and II medical devices.
• Preferably affinity and experience with the development of Software as a Medical Device (SaMD) in the digital health-based diagnostic / IVD arena.
• Working knowledge of FD&C Act and CLIA Waiver implementing regulations
• Demonstrate strong writing and communication skills
• Strong interpersonal skills and attention to detail
• Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
• Proficient knowledge of overall business environment, the orthopedic industry and the marketplace
• Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
• Able to identify risk in regulatory strategies
• Robust product knowledge
• Advanced anatomic knowledge
• Proven analytical and negotiation skills
• Experience with solving problems and concerns
• Intermediate computer skills, including Microsoft Office Suite
• Ability to lead a team and influence others
• Proficient knowledge of FDA and EU IVDR regulations (including labeling regulations) and regulations outside of the US/EU
Education/Experience Requirements
• US Bachelor’s Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
• Advanced degree preferred
• A minimum of 5-7 years of experience in Regulatory Affairs required
• A minimum of 2 years of experience in orthopaedic or in-vitro diagnostic device industry preferred
• Previous hands-on experience with the Regulatory processes behind the compilation of 510(k)s, Q submissions, CLIA Waiver highly preferred
• Regulatory Affairs Certification (US or EU) preferred
• A combination of education, experience, leadership, strategy and RA influence may be considered
Travel Requirements
Up to 15%
Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
To apply, please follow the links below.
https://www.zimmerbiomet.com/en/about-us/careers/job-details.477132.html
https://www.linkedin.com/jobs/view/regulatory-affairs-senior-specialist-738950-at-zimmer-biomet-3540956404/
Posted Date: 2/8/2023
Position Title: Director, Regulatory Affairs, Beaufort
Beaufort seeks a skilled Director, Regulatory Affairs to work alongside a top-notch team of clinical research and technology professionals.
Position Summary:
The Director, Regulatory Affairs will use his/her regulatory, scientific, and business management knowledge to provide value-added scientific and strategic solutions aimed at successful market authorizations to Beaufort’s primarily in vitro diagnostic clients. prepare and submit complex regulatory documents. The successful candidate will possess strong knowledge of FDA and international pertaining to in vitro diagnostics (IVD) and will be responsible for leveraging that expertise to support Beaufort’s Regulatory area practice objectives. The Director, Regulatory Affairs will perform work independently as a client-facing lead or as a contributor to regulatory projects within the stated scope of work and timeframes as established with clients.
Key Responsibilities:
This is a key position at Beaufort. As such, we ask the education and/or experience you hold includes the following:
Please contact Judie Jaquis, Recruiting Manager at [email protected] or at LinkedIn https://www.linkedin.com/in/judie-jaquis-27888313 for more information. To apply directly please follow the link: Recruitment (adp.com)
Position Title: Director, Regulatory Affairs, Beaufort
Beaufort seeks a skilled Director, Regulatory Affairs to work alongside a top-notch team of clinical research and technology professionals.
Position Summary:
The Director, Regulatory Affairs will use his/her regulatory, scientific, and business management knowledge to provide value-added scientific and strategic solutions aimed at successful market authorizations to Beaufort’s primarily in vitro diagnostic clients. prepare and submit complex regulatory documents. The successful candidate will possess strong knowledge of FDA and international pertaining to in vitro diagnostics (IVD) and will be responsible for leveraging that expertise to support Beaufort’s Regulatory area practice objectives. The Director, Regulatory Affairs will perform work independently as a client-facing lead or as a contributor to regulatory projects within the stated scope of work and timeframes as established with clients.
Key Responsibilities:
- Work with Beaufort and Client teams by combining deep regulatory experience with insight into client pressures to develop the right solution for the client. This requires developing in-depth project management skills and business understanding, knowledge, and experience to make effective decisions and take action.
- Work directly with clients to complete large, complex or multi-year programs and/or provide direction to resources in order to achieve operational excellence, delivering projects/programs on time, to budget, to the highest quality, and that exceed client expectations.
- Draft complex regulatory submissions, including PMAs and IVDR Technical Documentation for a wide range of diagnostic products, including companion diagnostics.
- Support client regulatory agency interactions for products under review, ensure timely responses and communications, and successfully navigate through the process to secure registrations
- Critically review client provided QMS documentation to support quality assurance and/or regulatory submissions, including software/cybersecurity documentation, analytical and clinical study protocols and reports, IVDR technical documentation to assess quality, to identify gaps, and provide mitigations.
- Evaluate project team performance against budget and timeline parameters and adjust as needed to maintain client/project expectations.
- Provide managerial oversight, as well as develop and mentor new employees as needed to support departmental growth.
- Regularly communicate with staff to assure effective two-way information flow (i.e. business updates, project updates, staff interests, issues, and/or concerns).
- Support and expand visibility as a regulatory subject matter expert and thought leader through industry event participation, speaking engagements, and industry panels.
- Monitor, identify, and understand new regulatory requirements, policy changes, and other market developments that may impact regulatory strategies for clients.
This is a key position at Beaufort. As such, we ask the education and/or experience you hold includes the following:
- Bachelor’s degree in a scientific related field (e.g. Biochemistry, Biological Engineering, Chemistry, or similar); Master’s degree and/or other advanced degree, strongly preferred.
- 8+ years of regulatory affairs experience in in vitro diagnostics.
- Regulatory knowledge:
- Regulatory agency structure, processes, and key personnel.
- Experience in Companion/Complementary Diagnostics, and has lead company-sponsored interactions with regulatory bodies, especially FDA
- Demonstrated experience with writing regulatory submissions and obtaining approvals in the area of in vitro diagnostics (IVD) Class III (PMAs), preferably Companion Diagnostics.
- Working knowledge of Clinical Operations (e.g. GCP and study conduct, analytical testing, etc.).
- Demonstrated working knowledge of European Regulations (IVDR Technical Documentation requirements, Classification & Conformity Assessments, etc.).
- Working knowledge of other regulatory regimes including Japan, etc. preferred.
- Must have ability to handle multiple projects in fast-paced environment and exercise sound judgment.
- Must have demonstrated ability to manage small teams, and to perform successfully in cross-functional teams, with the ability to lead and mentor.
- Must have excellent interpersonal, strategic thinking, communication, and organizational skills.
- Experience managing remote staff is preferred.
- Ability to travel (up to 10% post Covid).
Please contact Judie Jaquis, Recruiting Manager at [email protected] or at LinkedIn https://www.linkedin.com/in/judie-jaquis-27888313 for more information. To apply directly please follow the link: Recruitment (adp.com)
Posted Date: 2/2/2023
Position Title: Senior Regulatory Affairs Specialist.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Regulatory Affairs Specialist, you will be responsible for:
Required skills to have for the success of this role
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Why you’ll love working for Siemens Healthineers
If you’d like to learn more about this position, please contact Nancy Dye at [email protected]
Position Title: Senior Regulatory Affairs Specialist.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Regulatory Affairs Specialist, you will be responsible for:
- Developing and executing regulatory strategies for assigned projects to successfully register IVDs in U.S., EU, Canada, Japan, China and worldwide.
- Serving as the Regulatory Affairs representative on product core teams to ensure the assays developed are high quality and have been tested according to worldwide regulatory requirements.
- Reviewing technical plans and reports to ensure data accuracy, traceability and compliance to standards (e.g. ISO, CLSI).
- Reviewing and approving product labeling, advertising/promotional material, verification plans and reports.
- Participating in internal and external audits (as auditee and audit support).
- Reviewing new regulations or guidance documents and assessing their impact to the business.
- Developing new procedures or enhancing existing processes to facilitate efficient and effective business practices.
- Companion Diagnostics and Pharma /Biopharmaceutical experience a plus
Required skills to have for the success of this role
- BS in Science, Engineering or related discipline MS in Science, Engineering or related discipline preferred
- 3-10 years regulatory affairs experience with FDA and EU regulations ( or equivalent )
- Experience with immunoassays
- Experience in assay development or in a technical role in manufacturing
- Good technical writing skills
- Proficiency in reading, interpreting and summarizing technical reports
- Clear communication skills (both written and oral) and strong presentation skills, with a firm grasp of target audiences
- Creative and adept at problem solving
- Great focus with attention to detail
- Able to multi-task and work effectively in a dynamic environment
- Skilled in Outlook, Adobe Acrobat and Microsoft Office applications (including macros and Excel functions)
- Demonstrated ability to complete assignments independently and in teams
- Experience building consensus, presenting convincing arguments and overcoming objections
- Strong scientific background and understanding how changes could impact assay performance.
- Intercultural sensitivity
- Participation in industry groups and standard development committees preferred
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Why you’ll love working for Siemens Healthineers
- Be part of exciting and innovative projects that help solve some of the world’s most significant health problems.
- Engaging, challenging, and fast evolving, cutting edge technological environment.
- Opportunities to advance your career.
- Competitive total rewards package.
- Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities.
- Participate in our celebrations and social events.
- Opportunities to contribute your innovative ideas and get paid for them!
- Employee perks and discounts.
- Great Place to Work Certified 2022
- Best Places to Work for LGBTQ Equality
- Best for Vets Employers by Military Times
- Glassdoor Employer Rating: 4.0
If you’d like to learn more about this position, please contact Nancy Dye at [email protected]