Regulatory Affairs Specialist EMEA
Core
Provide advanced regulatory support for New Product Development, market expansion, and sustaining operations for medical devices across EMEA.
Role type
Regulatory Affairs Specialist
Builds
Medical device registration dossiers and compliance strategies for EMEA markets
Domain
Medical Devices / Regulatory Affairs
Required skills
Medical device registration lifecycle management, Regulatory impact assessments, EU MDR 2017/745 knowledge, ISO 13485 knowledge, Change notification strategies, Cross-functional coordination, Regulatory database management
Preferred skills
Engineering or Medical Technology degree, C1 English proficiency, Project management, International team leadership
Technologies
EU MDR 2017/745, ISO 13485, RoHS
Responsibilities
Assess regulatory impact for new markets and product expansions, Manage preparation and submission of EMEA medical device registration dossiers, Coordinate registration strategy with cross-functional partners, Monitor and evaluate changes in medical device regulations, Support audits, inspections, and compliance activities
Seniority
Mid-Senior, hands-on IC