In this role, you will have the opportunity to:

+ Lead and oversee risk management activities across the full lifecycle of medical diagnostic devices.

+ Ensure that product risks are systematically identified, evaluated, controlled, and monitored in compliance with global regulatory and industry standards.

+ Serve as the subject-matter expert on ISO 14971, partnering closely with Systems Engineering, R&D, Quality, Regulatory Affairs, Manufacturing, Clinical, and Post-Market Surveillance teams to deliver safe, compliant, high-quality products.


The essential requirements of the job include:

+ A bachelor’s degree in Engineering or Science, along with a mandatory ISO 14971 Risk Management certification from a recognized, accredited organization.

+ 10+ years of hands-on experience in Medtech development, with strong expertise in Risk Management and Systems Engineering.

+ Proven ability to lead and execute end-to-end risk m...