Bachelor's degree in a Scientific or Engineering field (e.g., Biomedical Engineering, Life Sciences), or equivalent practical experience.
10 years of experience in design quality and safety risk management in the medical device industry with focus on Software as a Medical Device.
Experience applying medical device requirements to software as a medical device and Artificial Intelligence (AI), including launching and managing the lifecycle of Business-to-Consumer (B2C) Digital Products.
Experience in supporting regulatory audits and Inspections.
Preferred qualifications:
Master’s degree in a Scientific or Engineering field (e.g., Biomedical Engineering, Life Sciences), or equivalent practical experience.
Professional certification in Quality, Safety or Regulatory affairs.
Experience in handling safety risk assessments for cloud based software as medical devices.
Experience with global safety standards and regulations e.g. FDA Quality System Regulation, ISO 13485, ISO 14971, DCB 0129, IEC 62304, AAMI TIR 45 and IEC 62366.
Knowledge of Generative Artificial Intelligence (AI) and Machine Learning (ML) models.
Ability to guide product development teams, navigate regulatory pathways and meet quality/safety standards.