Director, Regulatory Affairs – AWB
Core
Develop and implement global regulatory strategies for the Advanced Wound Bioactives (AWB) portfolio, including biologics, HCT/Ps, and device-led combination products.
Role type
Director, Regulatory Affairs
Builds
Regulatory submissions (510(k), sBLA, Health Canada) and team leadership for biologics and HCT/P products
Domain
Medical Devices / Biologics / Wound Care
Required skills
FDA BLA/sBLA CMC submissions, 510(k) and Q-submissions, HCT/P regulation, international medical device regulatory agency interactions, strategic risk evaluation, cross-functional leadership
Preferred skills
Sec 361 regulated HCT/P experience, complex program management
Technologies
510(k), sBLA, Health Canada submission systems
Responsibilities
Lead regulatory strategy for AWB portfolio, mentor regulatory team across multiple locations, support FDA audits/inspections, ensure compliance with domestic and international laws
Seniority
Director, strategic leadership & team management
