GRA Device Associate - Medical Devices and Combination Products (Senior Manager)

Sanofi•Morristown, NJ

3d•Hybrid

About The Position

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.

Requirements

Bachelor's degree in a scientific or engineering discipline.
6+ years of relevant pharmaceutical OR 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, and persuasive negotiation skills.
Demonstrates strategic thinking, initiative, change agent leadership, and risk assessment proficiency, including the ability to integrate overall business objectives into actionable project strategies.
Strong written and verbal communication and influencing skills, with fluency in English.

Nice To Haves

Advanced degree (Master or PhD) preferred.

Responsibilities

Partner with the Device Regulatory Lead on assigned projects.
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.
Contribute to and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elements.
Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions
Identifies medical devices regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT.
Identify issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.
Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
Liaises with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes.
Prepare and review 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 medical devices Health Authorities for projects/products in their remit, as needed.
Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management.
Contribute to internal regulatory processes and procedures for device/IVD.