Senior Regulatory Affairs Specialist

Key Responsibilities: Prepare, update, and maintain regulatory documentation (including Technical Documentation, DoC, GSPR) in line with EU MDR requirements. Route regulatory documents for internal approval using PLM systems. Conduct regulatory assessments as part of the Change Control process. Collaborate with cross-functional teams (Quality, Operations, R&D) and external partners (suppliers, distributors) to gather required documentation for compliance and regulatory submissions. Review produ…