About the Job

The Senior Specialist, Regulatory Affairs performs activities to support the regulatory submissions process through development of regulatory strategy and submission of materials to health authorities such as FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document packages for regulatory 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 regulatory submissions to expand indications of currently marketed products; documents include, but are not limited to:
• Significant Risk Determination Requests (SRDs);
  • IDE applications;
  • Pre-market applications (PMAs, sPMAs); 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 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 FMI’s values: passion, patients, innovation and collaboration

#LI-Hybrid