Regulatory Affairs Manager M/F/X (CDI)
Core
Lead Regulatory & Compliance activities for ENTD, Ophthalmic, and Inhalation medical devices and combination products, managing the regulatory team and supporting customers in notification procedures across EU, US, and Canada.
Role type
Senior Regulatory Affairs Manager (Team Lead)
Builds
Regulatory strategies, compliance documentation, and normative compliance for medical device product platforms.
Domain
Medical Devices (ENT, Ophthalmic, Inhalation) / Regulatory Affairs
Deliverable
client delivery
Required skills
Team management, Regulatory strategy development, ISO 13485 QMS, ISO 14971 Risk Management, MDR 2017/745, IEC 62304, ISO 10993, Gap analysis, Standardization committee participation
Preferred skills
Combination Products experience, Multicultural environment experience, Transversal project leadership
Technologies
MDR 2017/745, IEC 62304, ISO 10993, ISO 13485, ISO 14971
Responsibilities
Manage the Regulatory & Compliance team for specific business units, Define regulatory strategies and impact assessments for product changes, Support customers in notification procedures (EU, US, Canada), Collect and interpret monitored standards for normative compliance, Participate in standardization committees and external expert groups, Conduct in-depth analysis of product changes and propose corrective measures.
Seniority
Senior, hands-on IC with team leadership