Regulatory Affairs Officer
ScreenPoint Medical
full-time
Posted on:
Location Type: Hybrid
Location: Nijmegen • Netherlands
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Tech Stack
About the role
- Lead global submissions and registrations for new and existing products, with a primary focus on international markets (APAC, LATAM, Middle East and Africa)
- Advise the business on "where and when" to launch.
- Define efficient regulatory strategies, prioritizing markets based on commercial impact and regulatory complexity.
- Streamline regulatory processes, maximizing the reuse of technical documentation and approvals to minimize workload and increase speed-to-market.
- Monitor the evolving global landscape, assess the impact of regulatory changes, and provide clear guidance to engineering teams regarding product updates.
- Act as the primary regulatory point of contact for external partners (distributors, authorized representatives) and internal teams, ensuring priorities and timelines are perfectly aligned.
Requirements
- At least 3 years of experience in Regulatory Affairs for medical devices.
- Experience with international submissions and registrations (e.g. APAC, LATAM, Middle East and Africa).
- Excellent communication skills in English; ability to manage multiple timelines and external partners effectively.
- Experience with software as a medical device (SaMD)
- Strong understanding of medical device software regulations, including IEC 62304, ISO 14971, and evolving AI / cybersecurity frameworks.
- Experience with US and EU submission (510(k), de Novo, PMA, EU MDR)
- Experience with cloud-based or SaaS solutions.
- Direct interaction with Notified Bodies and/or FDA.
- Knowledge of breast radiology, oncology, and/or breast MRI workflows, including diagnostic flow and clinical practice.
Benefits
- Providing a Certificate of Conduct (VOG) or background check is part of our application procedure
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Regulatory AffairsInternational submissionsMedical device software regulationsIEC 62304ISO 14971510(k)de NovoPMAEU MDRSoftware as a medical device (SaMD)
Soft Skills
Communication skillsProject managementStakeholder managementTimeline management