GRA Device Associate- Digital Health

Sanofi•Morristown, MA

4d•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 Digital and Diagnostic team you’ll contribute to 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 influence the success of product approvals through strategic negotiations with health authorities worldwide. The GRA Device Associate-Digital Health role offers the opportunity to support a wide range of digital health technologies, from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and other innovative technologies. Working at the intersection of science and compliance, you'll propose regulatory 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.
5+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3 + years of regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
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
Strong written and verbal communication and influencing skills, with fluency in English.
Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth.

Nice To Haves

Graduate degree preferred.
Familiarity with implementing device regulatory strategies to support regulatory strategy for implementing DHTs into clinical trials to enable the development of digital endpoints and supporting SaMD development.
Familiarity with preparing regulatory documentation and standard submission processes.
Understanding of clinical development of medicinal products, device/IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets.
Working knowledge with technical/industry standards related to e.g., software development lifecycle, design controls, labelling, software documentation, risk management, clinical evaluations, and usability.
Ability to synthesize and critically analyse data from multiple sources.

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 DHT, digital biomarkers/endpoints, and SaMD elements
Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions
Identifies DHTs 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 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