Regulatory Affairs Manager M/F/X (CDI)
Core
Lead Regulatory & Compliance activities for ENTD, Ophthalmic, and Inhalation medical devices and combination products across the full product lifecycle.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory strategies, compliance documentation, and QMS improvements for medical device portfolios
Domain
Medical Devices / Pharmaceutical Industry
Required skills
Regulatory strategy, team management, ISO13485, ISO14971, MDR 2017/745, risk management, normative compliance analysis, stakeholder engagement
Preferred skills
Combination products experience, international committee participation, standardization committee involvement
Technologies
MDR 2017/745, ISO13485, ISO14971, IEC 62304, ISO 10993
Responsibilities
Manage Regulatory & Compliance team for specific business units; Define regulatory strategies and assess impact of product changes; Support customers in notification procedures (EU, US, Canada); Prepare and verify regulatory documents for submission; Conduct gap analysis and propose corrective actions; Participate in internal/external audits; Collaborate with development and production sites on normative compliance.
Seniority
Senior, hands-on IC with team leadership