The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to the FDA for approval of novel platforms. The position prepares document packages for FDA or other US regulatory body agencies and ensures compliance with all requirements.
Key Responsibilities
Represent the regulatory affairs function on assigned cross-functional project teams.
Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market.
Write, prepare, edit and review FDA submissions using templates to expand indications of currently marketed products; documents include, but are not limited to:
Significant Risk Determination Requests (SRDs);
IDE/IND Applications;
Pre-market applications (NDAs, PMAs, BLAs); and,
Post-market reports.
Support and eventually manage interactions with regulatory agencies including responses to regulatory inspections and regulatory submissions.
Support companion diagnostic regulatory strategy (analytical and clinical validation) and regulatory filings.
Review validation protocols and reports for regulatory submission soundness.
Publish electronic regulatory submissions.
Represent FMI before regulatory authorities and biopharmaceutical partners on regulatory and technical matters, as needed.
Provide support for marketed products, e.g., review engineering changes, labeling, promotional material, and product changes for compliance.
Support change control activities that require regulatory agency approval per US regulatory requirements.
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects.
Draft submission documents with other subject matter experts as needed.
Review and edit technical documents to be included in submission, which may include software validation protocols and reports and/or other software development documentation.
Other duties as assigned.
Qualifications
Basic Qualifications
Bachelor's Degree and 3+ years of professional work experience; OR,
Master's Degree and 1+ year(s) of professional work experience
Preferred Qualifications
Direct experience working with the Center for Devices and Radiological Health (CDRH), including writing and submitting pre-sub, IDE application and/or PMA documents to FDA CDRH
working cross-functionally on complex projects involving assay, instrumentation and software
attending meetings with FDA
Experience with companion diagnostics
Expertise in regulatory strategy
Regulatory compliance knowledge of FDA IVD requirements and understanding of validation design typical for FDA IVD submissions
Familiarity with device design control process and regulatory role in process
Outstanding interpersonal skills that include excellence in written communication, oral communication, negotiation, collaboration and problem-solving
Strong attention to detail and organizational skills
Understanding of HIPAA and importance of patient data privacy
Commitment to reflect FMI's values: passion, patients, innovation and collaboration
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.
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)
