Regulatory Compliance Commercial Specialist - temporary role until October 2027
Core
Coordinate and ensure timely execution of routine and cross-functional compliance activities for medical devices under EU MDR and Swiss MedDO frameworks.
Role type
Regulatory Compliance Commercial Specialist
Builds
Regulatory compliance for medical device products and commercial operations
Domain
Medical Devices / Regulatory Affairs
Required skills
EU MDR knowledge, ISO 13485:2016 knowledge, regulatory surveillance, economic operator management, audit support, product lifecycle management, quality agreement execution
Preferred skills
Lead auditor certification for ISO 13485, knowledge of WW regulations
Technologies
Microsoft Word, Excel, PowerPoint, Outlook
Responsibilities
Manage customer regulatory inquiries and tender support, perform product compliance verification, manage Economic Operator notifications, support audits and inspections, lead regulatory activities for product lifecycle, participate in field activities to identify compliance gaps
Seniority
Mid-level, hands-on IC