Sr Regulatory Affairs Specialist
$101,440–$126,800 year
HybridBoston, Massachusetts, United States
Job Summary
Represent the regulatory affairs function on cross-functional project teams to support regulatory submissions for in vitro companion diagnostic medical devices in the US market. Write, prepare, edit, and review regulatory submissions including Significant Risk Determination Requests, IDE applications, Q-Submissions, PMAs, and Performance Study Applications. Manage interactions with regulatory agencies, including responses to inspections, while reviewing validation protocols for submission soundness. Publish electronic submissions and represent the company before regulatory authorities and biopharmaceutical partners on technical matters. Provide guidance to internal development teams on regulatory strategy and compliance for marketed product changes. This role supports the development of novel platforms and requires direct experience with FDA CDRH submissions.
Required Qualifications
- Bachelor's Degree
- 3+ years of professional work experience
- Master's Degree
- 1+ year(s) of professional work experience
Desired 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 and other health authorities
- Professional and/or academic experience: interpreting scientific data, including clinical data
- successfully managing multiple concurrent regulatory submissions
- 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 the importance of patient data privacy
- Commitment to reflect FMI's values: Integrity, Courage, and Passion
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