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 noble mission: to save the lives of 250000 people within the next decade by revolutionizing skin care management. Our cutting-edge technology empowers users to take control of their skin health allowing for early detection of skin cancer signs from anywhere anytime. As our AI-powered medical device reaches more users across more markets ensuring its safety reliability and regulatory compliance becomes ever more critical - and that demands world-class risk management at the heart of everything we do. This is where we need you!

The Opportunity

We are looking for an experienced Safety & Risk Manager to join our Clinical & Regulatory Affairs this newly created role you will take full ownership of safety risk management across the lifecycle of SkinVisions 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 SkinVisions technical documentation including: Risk Management Plans; Hazard analyses and risk matrices; Risk control measures and residual risk evaluations; Benefit-risk evaluations; 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 SkinVisions risk management processes templates and governance structures.

• Provide training and guidance to internal teams on safety risk management methodologies.

• Bachelors or Masters 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(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.