GRA Device Associate- Digital Health

Job title: GRA Device Associate-Digital Health Location: Cambridge, MA About The Job 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. Ready to get started? 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. 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 – 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. Main 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 About You Education & Experience: Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred. 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. Soft Skills 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. Preferred Qualifications Regulatory Expertise: 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. Technical Knowledge: 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. Why choose us? Bring the miracles of science to life alongside a supportive, future‑focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well‑crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave. Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real‑world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Work at the forefront of drug discovery, harnessing cutting‑edge AI, data, and digital platforms to push the boundaries of science. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affor­mative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. #J-18808-Ljbffr Sanofi