Cambridge | Massachusetts | United States
ABOUT FOUNDATION MEDICINE
Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
ABOUT THE JOB
The Director, Regulatory Affairs is responsible for leading the regulatory function and its activities, the development of regulatory strategy, and supporting the regulatory approval process of materials for FMI data products or platforms that leverage data from those products. The position develops regulatory strategy for use of Real-World Evidence (RWE) in drug, device and diagnostic submissions. The incumbent functions as the regulatory subject matter expert for the FMI Data Products team and is embedded within that organization to enable close bidirectional collaboration. This position supports the regulatory approval processes of the US FDA, and may support approval through EMA, PMDA and others.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)