GRA Device Lead; Associate Director - Digital Health

Overview

Job Title: GRA Device Lead (Associate Director) - Digital Health
Location: Cambridge, MA/ Morristown, NJ

The Global Regulatory Affairs (GRA) Device team supports medical devices, combination products, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio. The team is part of the GRA CMC & GRA Device Department within Global R&D and provides expert guidance on medical device regulatory requirements across the product lifecycle. The team develops and implements global regulatory strategies for device and IVD products, leads regulatory efforts in development and post-marketing stages, and collaborates with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, and Regulatory Health Authorities.

As GRA Device Lead in the GRA Device Digital and Diagnostic team you’ll drive global regulatory strategies for medical device and digital health technologies, collaborate with cross-functional teams to navigate regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through negotiations with health authorities worldwide. This role supports a wide range of digital health technologies (DHTs), including digital biomarkers, wearables, software as a medical device (SaMD), connected devices, and other innovative technologies.

You’ll develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities, while preparing high-quality regulatory submissions, maintaining compliance, and anticipating regulatory trends.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering growth. Our pipeline enables us to invent medicines and vaccines that treat and protect millions of people worldwide, supported by a diverse portfolio of medical device and diagnostic products.

Main Responsibilities

• Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products).
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.
• Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements.
• Define device Health Authority interactions plan, lead device-related health authority interactions and support cross-functional health authority interactions.
• Identify DHTs regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT.
• Identify and manage issues and opportunities that impact submissions timelines; ensure communication, resolution and/or escalation as needed.
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions.
• Coordinate with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes.
• Prepare, review and approve design control deliverables.
• Contribute to product development and lifecycle management planning; provide regulatory impact assessments for proposed product changes.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed.
• Participate in the development and monitoring of the global regulatory environment and updating standards and processes related to device regulations.
• Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in device committees and forums.
• Support operational and compliance activities for assigned deliverables, develop, execute regulatory submission planning activities, including generation of submission content plans, submission tracking, communication and document management.
• Contribute to internal regulatory processes and procedures for DHTs.
• Accountable for regulatory assessment for DHTs Due Diligence activities as applicable.

May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes additional responsibilities:

• The dGRL is the fully…