• Provide strategic oversight of clinical research studies globally to ensure regulatory compliance • Lead global regulatory submissions and safety reporting across pre-market and post-market clinical research studies • Oversee the development of documents to meet EU MDR requirements • Conduct gap analyses and implement procedural updates based on evolving regulations • Ensure timely and accurate global safety reporting in compliance with 21 CFR 803, ISO 14155, and MDCG guidance • Manage and mentor a team of regulatory specialists, clinical writers, quality specialists and safety professionals