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

About the role

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.

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 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. You'll propose device strategies, conduct risk assessments, and interact with regulatory authorities while collaborating across R&D, Device, Manufacturing, and Quality teams.

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.
• Identify medical devices regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT.
• Identify issues and opportunities that impact submissions timelines; ensure appropriate communication, resolution, and/or escalation as needed.
• Support global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions.
• Liaise 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.
• Support operational and compliance activities for assigned deliverables, develop, execute 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.

Requirements

• Bachelor's degree in a scientific or engineering discipline. Advanced degree (Master or PhD) preferred.
• 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.

Skills

• 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 of 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.
• Strong leadership, influencing, and persuasive negotiation skills.
• 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.

Benefits

• Opportunities to grow your talent and drive your career, whether through promotion or lateral move, at home or internationally.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks’ gender-neutral parental leave.
• Pioneering biopharma company that engages patients early in drug development and uses their insights to design studies reflecting real-world needs.
• 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 Affirmative Action employers.