Regulatory Affairs Consultant (SaMD)
Regulatory Affairs Consultant - Software as a Medical Device (SaMD)
Location: Amsterdam, Netherlands (Remote/Hybrid)
Length: 12 months
Start Date: January 2026
About the Role
We're looking for an experienced consultant to advise on regulatory and quality strategies for software-driven medical technologies. This role is ideal for someone who understands the complexities of compliance for digital health solutions and can guide clients through the entire product lifecycle-from concept to market approval.
What You'll Do
- Partner with clients to determine compliance pathways for software-based medical products, including diagnostic, therapeutic, monitoring, and decision-support applications.
- Review development plans, technical documentation, risk files, and validation protocols to ensure alignment with global standards (FDA, IEC 62304, ISO 13485).
- Advise on building and maintaining quality systems tailored to software medical devices, including lifecycle processes, configuration control, and verification/validation activities.
- Support preparation of regulatory submissions for U.S. and international markets (e.g., 510(k), de novo, PMA).
- Conduct gap analyses on development workflows and quality systems to identify compliance risks and improvement opportunities.
- Collaborate with engineering, QA, regulatory, and clinical teams to embed regulatory requirements throughout development.
- Assist with regulatory communications, including meetings and responses to authorities or notified bodies.
What We're Looking For
- Degree in computer science, engineering, life sciences, or related field (advanced degree preferred).
- 5+ years in regulatory affairs, QA, or software development within the medical device sector, with hands-on experience in SaMD compliance.
- Deep knowledge of FDA regulations and relevant standards (IEC 62304, ISO 13485).
- Proven success in bringing software-based medical products to market, including apps and cloud-based solutions.
FAQs
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