Senior Regulatory CMC Drug-Device Combination Product Lead

Role: Senior Regulatory CMC Device and Combination Product Lead, responsible for developing and executing global regulatory strategies for medical devices and combination products. Key responsibilities include authoring and coordinating regulatory submissions, providing guidance on compliance with industry standards, representing the Regulatory CMC function in cross-functional teams, and monitoring legislative changes impacting regulatory practices. Collaboration involves working closely with product development, quality, and regulatory teams to ensure successful product registration and compliance across regions. Qualifications: Minimum of a bachelor’s degree and 5+ years in regulatory affairs within the medical device, biotech, or pharmaceutical sectors, with in-depth knowledge of cGMP, relevant regulations, and standards for combination products. Preferred: Degree in Life/Health Sciences or Engineering. Experience in regulatory submissions, risk management, and global regulatory landscapes are essential. High-Value: Focus on medical devices and combination products, regulatory submissions for registration and post-approval, compliance with cGMP, global regulatory intelligence, and cross-functional stakeholder engagement. Work setup details are not specified.