Digital Device Quality Expert - SaMD

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need. It’s about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before.

The Device Quality Expert will be accountable for the Software Quality Engineering, Risk Management and Supplier Control support of Software as Medical Device (SaMD) by leading all cGMP compliance activi-ties, as well as compliance with relevant domestic and international regulations, standards and guide-lines and customer requirements.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• BS/M.Sc. or equivalent degree in science or engineering (e.g. software engineering, systems engineering, electrical engineering, or related engineering degree)

• 6+ years’ experience in medical device product development focused on quality engineering related activities.

• 2 – 3 years relevant experience in risk management for medical devices

• Strong experience in software development and medical device life cycle management

• Good knowledge of and experience in performing safety and cybersecurity risk management for medical devices

• Proficient in usage of risk assessment methods, e.g.: Hazard Analysis (PHA), Software Risk Analysis, Fault Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA)

• Good knowledge of medical device regulations and international standards, e.g.: ISO 13485, 21 CFR 820, IEC 62304, ISO 14971, TIR 57, MDR, ISO/TR 80001, IEC TR 80002-1

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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