About the Job

The Regulatory Affairs Specialist 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 next-generation sequencing (NGS)-based companion diagnostic assays in the US, EU and Japan.
• Write, prepare, edit, and review FDA submissions using templates to expand indications of currently marketed products; documents including, but not limited to:
  • Significant Risk Determination Requests (SRDs);
  • IDE Applications;
  • Pre-market applications (PMAs and PMA supplements); and,
  • Post-market reports.
• Write, prepare, edit, and review submissions to New York State Department of Health.
• Write, prepare, edit, and review submissions to expand indications of currently marketed products in the EU (IVDR).
• Support regulatory submissions for Japan.
• 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 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 2+ years of professional experience in device, biotechnology, life science or healthcare regulatory affairs; OR 
• Advanced Degree (Master's Degree or higher) without experience

Preferred Qualifications:

• 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
• Familiarity with regulations for laboratory developed tests (LDT)- CAP/CLIA & regulatory submissions to NY State Department of Health (DoH)
• 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
• Professional and/or academic experience:
  • interpreting 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
• 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

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