Manager Regulatory Affairs (m/f/d)Penzberg, Germany
Foundation Medicine dedicated to transforming the way in which patients with cancer are diagnosed and treated. At Foundation Medicine you will work with everyone fighting the disease—patients and their families, payers, physicians, drug developers—to raise awareness about the ongoing evolution in cancer care and to ensure we are delivering the analytic tools and molecular information required to bring the promise of personalized cancer care into routine clinical practice. As a member of our International Product Development department, you will be responsible for distilling the latest advances in genomic science, technology and clinical data into innovative, best-in-class clinical diagnostic tools and data products that will enable oncologists to determine the best treatment throughout each patient’s journey with cancer.
Summary of Position:Foundation Medicine is seeking a Manager of Regulatory Affairs. This position will lead Regulatory Affairs activities at FMI Germany GmbH in Penzberg, Germany to support development and submission of materials to the EU regulatory authorities. This role will have the unique opportunity to contribute to the development of the regulatory strategy in the rapidly growing field of diagnostic next generation sequencing as well as to gain substantial tactical experience in developing and delivering regulatory submissions.
- This role requires the ability to draft submission documents and pull in subject matter experts as needed.
- Assessing compliance with the relevant regulation for in vitro diagnostic medical devices (IVD-R)
- Review and edit technical documents to be included in submission, which may include validation protocols and reports and/or software documentation.
- Compile; prepare; review submit and update regulatory submission to authorities
- Monitor impact of changing regulations on submission strategies and update internal stakeholders
- Evaluate proposed process changes for regulatory filing strategies
- Primary point of contact for all regulatory authority requests or act as company representative.
- Provide regulatory input for product recalls and recall communications
- Assist with development of RA strategy for assigned project in collaboration with the Regulatory Affairs group.
- Act as local regulatory representative in global project meetings as needed.
- Must have experience in writing and submitting of submission documents and technical documentation.
- Must understand device design control process and regulatory role in process.
- Must have regulatory compliance knowledge of IVD-R requirements.
- Must be fluent in German and English
- Experience attending meetings or audits from regulatory authorities and Notified Bodies.
- Must be detail oriented with excellent prioritization and organizational skills.
- Must be able to deliver results on schedule in a fast-paced, dynamic environment.
Desired Skills and Background:
- EU Notified Body experience is preferred
- Experience working on a companion diagnostic or other IVD.
- Scientific background in molecular biology and understanding of NGS technologies.
- Regulatory review of device change control and post-market change notification.
- MS or PhD with 5+ years of Regulatory experience ideally in diagnostics, but will consider pharma, biotech, medical device industry experience.
How to Apply:Please send your application documents by e-mail to firstname.lastname@example.org
Who should I contact if I have any questions?Contact: Dr. Thomas Holtschke E-mail: email@example.com https://www.foundationmedicine.com
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