Regulatory Affairs Specialist supporting medical device product development, market expansion, and compliance across EMEA regions. Manages registration dossiers, regulatory submissions, and cross-functional coordination to ensure adherence to EU and integral medical device regulations.
Responsibilities
- Assess regulatory impact and support market entry, product expansion, and new product introduction across EMEA
- Manage preparation, submission, and maintenance of medical device registration dossiers per local regulations
- Coordinate registration strategy with Product Lifecycle Management, Supply Chain, Marketing, and Commercial teams
- Monitor regulatory changes, perform sustaining activities including renewals and amendments for assigned markets
- Conduct regulatory impact assessments for design modifications, labeling updates,
software releases, and lifecycle changes
Requirements
- Bachelor's or Master's degree in Engineering, Medical Technology, or related field
- 5+ years medical device regulatory affairs experience with registration lifecycle management
- Advanced understanding of EU MDR 2017/745, ISO 13485, RoHS, and global regulatory standards
- C1 English proficiency in written and spoken forms
- Strong project management, organizational skills, and attention to detail
- Ability to lead cross-functional international team resolutions and manage project risks
- Proactive problem-solving and collaborative approach to teamwork