Key Responsibilities

• Support medical device risk management activities in accordance with ISO 14971, ensuring compliance throughout the product development lifecycle.
• Create, maintain, and update risk management documentation, including risk files and supporting technical documentation.
• Facilitate and contribute to risk analyses (e.g., FMEA), documenting hazards, risk evaluations, and mitigation activities.
• Collaborate with cross-functional teams to support structured product development, design controls, and timely project delivery.
• Identify documentation and process gaps, supporting continuous improvement for Class III blood-contacting cardiovascular devices.
  
  

Required Skills & Experience

• Demonstrated experience with ISO 14971 risk management for medical devices.
• Experience working on cardiovascular and/or blood-contacting medical devices (Class III preferred; e.g., ECMO, circulatory support, or similar).
• Hands-on experience conducting and documenting risk analyses (e.g., FMEA).
• Strong technical documentation and traceability skills within a regulated medical device environment.
• Ability to work effectively with cross-functional engineering, quality, and regulatory teams.
  
  

Please attach a copy of your CV where possible.