Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors

Role: Senior Director and Regulatory Platform Lead for GRA CMC, focusing on drug-device combinations and Human Factors. Responsibilities: develop and implement innovative regulatory strategies, ensure high-quality filings, serve as a global expert and influencer on Human Factors regulations, support regulatory interactions with authorities (FDA, EMA, Notified Bodies), author and review technical and regulatory documents, identify and mitigate regulatory risks, and lead cross-functional collaborations. Qualifications: BS/BA in Scientific, Pharmaceutical, or Engineering discipline; 10+ years in device or combination product regulatory roles within pharma or medical devices, including experience with global regulatory agencies and submissions (e.g., IND, BLA, MAA, 510(k)). Preferred: advanced degree, management experience, expertise in Human Factors, and international regulatory experience. High-Value: expertise in drug-device combination products, Human Factors, global health authority interactions, and regulatory strategy development. Work Setup: hybrid in Boston, MA, with approximately 10% travel.