Regulatory Affairs Specialist

3 days ago

Boston, Massachusetts, United States Foundation Medicine Full time

About the Role

The Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This position is responsible for developing regulatory strategies and submitting materials to health authorities, such as the FDA, for approval of novel platforms.

Key Responsibilities

  • Represent the regulatory affairs function on assigned cross-functional project teams, ensuring seamless collaboration and communication.
  • Assist in activities associated with regulatory approval of in vitro companion diagnostic medical devices in the US market, staying up-to-date with relevant regulations and guidelines.
  • Write, prepare, edit, and review regulatory submissions to expand indications of currently marketed products, including:
    • Significant Risk Determination Requests (SRDs)
    • IDE applications
    • Pre-market applications (PMAs, sPMAs)
    • Post-market reports
  • Support and manage interactions with regulatory agencies, including responses to regulatory inspections and 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, ensuring accuracy and compliance.
  • Represent Foundation Medicine before regulatory authorities and biopharmaceutical partners on regulatory and technical matters.
  • Provide support for marketed products, reviewing 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.

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 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 importance of patient data privacy.
  • Commitment to reflect Foundation Medicine's values: passion, patients, innovation, and collaboration.

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