Minimum 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.
- 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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About the job
In this role, you will partner with Googlers to ensure products meet the appropriate health regulations and data handling requirements, and translate quality and safety standards into actionable steps to enable safe, compliant, timely and trusted launches into markets globally. Google's health privacy experts support Privacy Working Groups (PWGs), Counsel and other horizontal teams on complex cases and the operationalization of new health privacy policies.
Google Health is a company-wide effort to help billions of people be healthier. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate, accessible, and equitable care. Our teams are applying our expertise and technology to improve health outcomes globally - with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community.
Responsibilities
- Navigate regulatory submissions to various regulatory authorities inEurope, Middle East, and Africa(EMEA) for Software as a Medical Device(SaMD) products. Work with experts and product teams in preparing, submitting, and managing applications, as well as communicate with regulatory authorities.
- Develop and maintain an understanding of relevant regional regulations, guidelines, and standards related to SaMD and provide strategic regulatory guidance to internal stakeholders, including Product teams, Clinical Affairs, and Legal teams, on development and commercialization strategies for the region.
- Collaborate with Google's Government Affairs team to ensure alignment on strategy and Google's position in the region.
- Build and maintain strong relationships with key industry stakeholders and relevant regulatory bodies in the region.
- Provide Safety, Risk Management expertise and guidance to the Product teams, ensuring consistent and accurate application of all Safety Risk Management standards.