GRA Device Lead; Associate Director - Digital Health

Job Title: GRA Device Lead (Associate Director) - Digital Health

Location: Cambridge, MA / Morristown, NJ

GRA Device Lead (Associate Director) - Digital Health

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health, and in‑vitro diagnostic products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle.

The team bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. It is accountable for developing and implementing global regulatory strategies for device and IVD products intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post‑marketing stages. The organization maintains strong collaborative relationships with Global Regulatory Affairs, Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.

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 complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide.

The GRA Device Lead role is a critical and highly visible position that offers the opportunity to support a wide range of digital health technologies (DHTs), from digital biomarkers and wearables to software as a medical device (SaMD), connected devices, and other innovative technologies. You will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities.

You will collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide.

About Sanofi:

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enable 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. Together, we chase the miracles of science to improve people’s lives.

• 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 the 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 DHT regulatory acceleration opportunities and regulatory risks, and propose risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution, and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable…