Safety & Risk Manager (AI / SaMD)

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 250,000 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!

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.

• 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.

• 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; 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.

• 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.

• 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).

• 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.

• 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.