Safety & Risk Manager (AI / SaMD)

For this role, we will only consider candidates who are currently based in the Netherlands.

About SkinVision

Skin cancer is a growing global concern, with 1 in 5 people at risk, yet only 3% of high-risk populations are known to health authorities. At SkinVision, we are on a mission to improve skin care management through AI-powered technology that helps users detect signs of skin cancer early. As our medical device reaches more users across more markets, ensuring its safety, reliability, and regulatory compliance becomes increasingly critical.

The Opportunity

We are looking for an experienced Safety & Risk Manager to join our Clinical & Regulatory Affairs team. In this newly created role, you will take full ownership of safety risk management across the lifecycle of SkinVision's AI-driven Software as a Medical Device (SaMD) products.

Today, safety risk management activities are distributed across multiple teams. As SkinVision scales its regulatory footprint and prepares for additional market authorisations, we are establishing this dedicated role to ensure consistent, high-quality risk management processes and documentation that meet the expectations of notified bodies, the FDA, and international regulators.

What You Will Do

Safety & Risk Management Leadership

• Lead and facilitate cross-functional safety risk management activities across the organization.
• Act as the internal subject matter expert for product safety and risk management.
• Support the development and maintenance of benefit-risk evaluations aligned with clinical evidence and post-market data.

Risk Management Documentation

• Own and maintain Risk Management Files as part of SkinVision's technical documentation, including Risk Management Plans, hazard analyses and risk matrices, risk control measures and residual risk evaluations, benefit-risk evaluations, and Risk Management Reports.
• Ensure traceability between hazards, safety requirements, design controls, verification and validation activities.
• Contribute to General Safety and Performance Requirements (GSPR) documentation (MDR Annex I), ensuring alignment with the risk management file.

AI / ML-Specific Risk Management

• Lead risk assessments for AI algorithm updates, including model retraining, performance drift, and data distribution shifts.
• Contribute to the development and maintenance of Predetermined Change Control Plans (PCCPs) aligned with FDA and IMDRF guidance.
• Ensure risk evaluation covers AI-specific hazards, including bias, edge cases, dataset representativeness, and algorithm transparency.
• Ensure risk controls are evaluated and updated when algorithm changes are introduced.
• Stay current with evolving regulatory frameworks for AI/ML in medical devices.

Clinical Safety & Post-Market Risk Evaluation

• Evaluate clinical safety signals from post-market surveillance, literature, and clinical evidence.
• Contribute to benefit-risk evaluations and ensure risk management is aligned with Clinical Evaluation Reports (CER).

Regulatory & Standards Compliance

• Ensure risk management processes comply with applicable EU MDR, ISO, IEC, FDA, and IMDRF requirements.
• Support EU MDR and FDA regulatory submissions by ensuring risk management documentation is complete and audit-ready.
• Support notified body audits, regulatory inspections, and certification reviews, including responses to risk-related questions.
• Collaborate with the Security Officer and Engineering teams to ensure cybersecurity risks are identified, evaluated, and controlled within the ISO 14971 risk management framework.

Product Development & Cross-Functional Collaboration

• Collaborate closely with Engineering, Product, Data Science, Clinical, Medical, and Quality teams to integrate risk management into product development workflows.
• Facilitate risk review sessions (e.g., FMEAs, design reviews, algorithm reviews) and ensure appropriate risk controls are implemented and verified.
• Ensure safety considerations are incorporated into new product features, algorithm updates, and product changes.
• Participate in change control and CAPA processes to evaluate risk implications of proposed changes.
• Strengthen and continuously improve SkinVision's risk management processes, templates, and governance structures.
• Provide training and guidance to internal teams on safety risk management methodologies.

Job requirements

Required

• Bachelor's or Master's degree in Biomedical Engineering, Software Engineering, Systems Engineering, Medical Technology, or a related field.
• 5+ years of experience in medical device development or regulated healthcare software.
• Proven experience with risk management for medical devices or Software as a Medical Device (SaMD).
• Strong knowledge of ISO 14971, EU MDR 2017/745, ISO 13485, and IEC 62304.
• Familiarity with FDA SaMD frameworks, including De Novo / 510(k) pathways and AI/ML guidance.
• Knowledge of IMDRF SaMD guidance, including risk categorization (N12).
• Experience applying risk analysis methodologies such as FMEA, FTA, and PHA.
• Experience working with cross-functional teams.
• Excellent written and verbal communication, facilitation, and technical documentation skills.
• Fluent in English and based in the Netherlands.

Preferred

• Experience with AI or algorithm-based medical software.
• Experience with EU MDR technical documentation and regulatory submissions to notified bodies.
• Experience with post-market surveillance, vigilance, and PMCF activities.
• Familiarity with benefit-risk evaluation in clinical contexts.
• Awareness of IEC 81001-5-1 (health software cybersecurity).
• Professional certification in regulatory affairs (e.g., RAC) or relevant ISO 14971 / risk management training from a recognised body.

Your personality

• A pragmatic, solutions-oriented approach - you know how to balance regulatory rigour with startup agility.
• Strong stakeholder management skills - you can translate technical risk concepts into clear language for diverse audiences.
• A genuine passion for patient safety and the role of technology in healthcare.

What We Offer

• A pivotal role in a growing digital health company at the forefront of AI in medical devices.
• The opportunity to shape and own the risk management function from the ground up.
• A collaborative, international team of professionals passionate about health technology.
• Hybrid working model with an office in Amsterdam.
• Competitive compensation and benefits package.
• Professional development opportunities, including conferences and training.