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Google Regulatory Quality Safety Expert Google Health United Kingdom, England, London 323799982
01.12.2024
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Minimum qualifications:
Preferred qualifications:
- 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.
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