GRA Device Associate - Medical Devices and Combination Products; Senior Manager
Listed on 2026-07-09
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Engineering
Medical Device Industry, Regulatory Compliance Specialist, Biomedical Engineer
Job title:
GRA Device Associate – Medical Devices and Combination Products (Senior Manager)
Location:
Morristown, NJ
The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic (IVD) 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.
Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team 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 team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.
As GRA Device Associate in the GRA Device General Medicine and Vaccine Medical Device and Combination Product team you’ll contribute to global regulatory strategies for medical device and combination products, collaborate with cross‑functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and influence the success of product approvals through strategic negotiations with health authorities worldwide.
The GRA Device Associate role offers the opportunity to support a wide range of combination products, from pre‑filled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll propose device strategies, conduct risk assessments, and interact with regulatory authorities. You'll 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.
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI‑powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About SanofiWe’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 – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.
Education- Bachelor’s degree in a scientific or engineering discipline.
- Advanced degree (Master or PhD) preferred.
- 6+ years of relevant pharmaceutical, biotechnology or medical device industry experience.
- 3+ years of regulatory experience (combination of CMC, device, and combination product) with contributions to regulatory filings and implementation of regulatory strategies.
- Experience responding to Health Authority questions.
- Familiarity with implementing device regulatory strategies to support product development, clinical use, and commercialization, including change controls.
- Familiarity with preparing regulatory documentation and standard submission processes.
- Understanding of drug clinical development, device development (including design controls), and working knowledge with technical/industry standards related to medical devices.
- Ability to work effectively in a matrix environment, engaging cross‑functionally with R&D, Device, Manufacturing, and Quality teams.
- Demonstrates business acumen, strong leadership, influencing,…
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