Regulatory Affairs Officer
ScreenPoint MedicalNijmegen, Gelderland, Netherlands
Posted February 10, 2026
Full Time
About the Company
ScreenPoint Medical is a leading company that develops and markets breast image analysis and cutting edge machine learning applications and services.
Job Description
Regulatory Affairs Officer role at ScreenPoint Medical, responsible for developing and implementing global regulatory strategies for medical software, leading global submissions, and streamlining regulatory processes. As a strategic architect of the company's global market presence, the successful candidate will navigate the complex intersection of medical devices, AI, and global compliance.
Requirements
- At least 5 years of experience in Regulatory Affairs with medical device software (SaMD)
- Proven track record of global regulatory submissions (e.g. EU MDR, US 510(k), PMA, De Novo, and RoW registrations)
- Strong understanding of medical device software regulations, including IEC 62304, ISO 14971, and evolving AI / cybersecurity frameworks
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Relocation Assistance
- Tuition Reimbursement
- Visa Sponsorship