Program Manager, Regulatory Affairs

Role: Regulatory Affairs Specialist for medical devices and biologics, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Responsibilities: develop regulatory strategies, prepare submissions for FDA and international agencies, support product changes, review technical reports, and ensure compliance with QSR, cGMP, ICH, FDA, and EU standards. Collaborate with process development, manufacturing, and quality teams to support domestic and global regulatory filings. Requirements: BS in science, technology, engineering, or mathematics; 5+ years of biotech regulatory experience; hands-on knowledge of medical device and biologic development, including submissions like PMA, IND, BLA, and 510(k). Preferred: advanced degree, RAC certification, familiarity with international biologics/drug/device regulations, and experience with product lifecycle management. HighValue: biologics/biomedical devices, HCT/Ps, regulatory submissions, FDA/International compliance, product lifecycle support, and cross-functional collaboration. WorkSetup: unspecified.