Title: Director Regulatory Affairs
A small sized diagnostics company is seeking a Director of Regulatory Affairs to lead the regulatory submissions, strategy, and maintenance activities for their existing products and new products in development. They are pioneering the field with innovative machine learning-based liquid biopsy mRNA expression tests, designed for both standard-of-care and pharmaceutical trials. These products are patented and unique to the cancer diagnostics market. This role reports directly into the CEO/CSO.
Responsibilities:
- Register two prospective studies with the FDA
- Serve as the point of contact for submissions to all notified bodies
- Manage all communications, meeting scheduling, meeting materials and meeting minutes with the FDA and other agencies including requests for meetings, advice, etc.
- Draft and formulate pre-sub and submission packages/dossiers, which include technical documents and data, e.g. assay validation protocols and reports, clinical reports/data and/or other development documentation.
- Develop, draft and author regulatory submission documentation, including traditional 510K, de-novo 510K, SRDs, IDEs, and PMAs.
- Develop regulatory strategies alongside the CSO
- Act as the lead Regulatory personnel represent
Qualifications:
- 6+ years of experience in IVD Regulatory Affairs
- Preferred experienced with LDTs
- Ideally experienced with oncology molecular tests, e.g. NGS, multiplex PCR, etc.
- Successfully authored and files 510k, de-novo 510/PMA, BTD submissions
- Hands on experience coordinating FDA procedures: planning FDA meetings, leading FDA meetings, taking notes for FDA meetings, etc.
- International IVD experience
- Robust understanding of LDT under CLIA/CAP, NYSDOH, and the FDA LDT Final Rule released May 2024.
