Digital Device Quality Expert - SaMD

Job Title: Digital Device Quality Expert - SaMD

Location: Cambridge, MA

About the Job

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. 

Our mission is to support the Sanofi business units by delivering differentiated services and solutions that help patients, physicians, care takers, payers as well as Sanofi to better take care of patients and provide an improved outcome to the healthcare system. Our services and solutions sit on top of our market leading technology platform which we continue to evolve.

We have recruited top talent in the field of Digital Health to help transform care in Diabetes, Speciality Care and beyond in the areas of Drug+ apps. Our team has released an FDA certified class II medical device titration application. We are gearing up for other software applications across the diabetes and speciality care journey, with external LMR partnerships.

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.

The position contributes directly to meeting regulatory submission and launch timelines of the software as medical devices products.

Furthermore, Device Quality Expert is responsible for applying quality engineering and risk management principles early on in the product development process and through the lifecycle to support a safe and effective product.

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:

Relationship Management with Stakeholders, Ensure Quality & Compliance of SaMD Products:

• Represent Digital Device Quality on cross-functional teams in support of SaMD activities, collaboration with the internal and external stakeholders (See item V for list of stakeholders)

• Plan for and provide appropriate Quality & Compliance support for the project and application portfolios of the SaMD Digital Health Technology teams

• Promote quality and compliance throughout the Product life cycle and implement processes, procedures and awareness and training on Quality Management System

• Provide quality engineering support for design and development, and facilitate the application of controls and risk management to ensure that SaMDs are designed to be safe, effective and in compliance with the applicable regulations worldwide.

• Work with cross-functional teams for, review and approval of design & development plans, requirements, specification development, engineering studies, design verification protocols and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.

• Lead and participate in design reviews

• Provide Quality impact assessment for product changes

• Provide quality input into CAPA and nonconforming product investigations

• Support root cause investigations and implementation of corrective actions

Risk Management:

• Lead all risk management activities according to ISO 14971 and TIR 57

• Plan, prepare and perform risk management activities for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.

• Ensure that all hazards, threats and vulnerabilities associated with a medical device are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are i