Key skills
Risk ManagementCollaboration
About this role
Role Overview
- Lead and execute regulatory strategy for certified SaMD and digital therapeutics
- Prepare, submit, and maintain documentation required for CE marking, FDA clearance, and global regulatory approvals
- Collaborate cross-functionally with product development, clinical, and quality teams
- Monitor evolving global regulations for digital health and provide strategic guidance
- Establish and oversee post-market surveillance activities
Requirements
- 4+ years in regulatory affairs for medical devices or digital health
- Strong understanding of SaMD, ISO 13485, IEC 62304, IEC 62366 and risk management under ISO 14971
- Experience leading CE mark submissions, FDA clearance and interacting with notified bodies
- Fluent in English; additional EU languages a plus
Benefits
- Remote-first culture
- Collaboration with cross-disciplinary teams passionate about patient outcomes