GRA Device Associate

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* Job Title:

** GRA Device Associate

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* Location:

** Cambridge, MA/ Morristown, NJ/ Washington DC

** About the Job*
* 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 (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 in-vitro diagnostic technologies, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and directly 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 diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents, and companion and complimentary diagnostics.  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.

** 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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

** 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 IVDselements

+ Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions

+ Identifies IVD 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…