GRA Device Associate- Digital Health

About the role

The Global Regulatory Affairs (GRA) Device team supports medical device, combination product, digital health and in-vitro diagnostic (IVD) products within the Sanofi portfolio. The team provides expert guidance on regulatory requirements and collaborates with various internal teams to ensure compliance and optimize product approval pathways.

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 digital health technologies, digital biomarkers/endpoints, and SaMD elements
• Contribute to device Health Authority interactions plan, support device related and cross-functional health authority interactions
• Identify DHTs 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 Health Authorities for projects/products in their remit, as needed
• Serve as a liaison with 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

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

• Expand your horizons. Grow through curiosity, with support to move, learn, and lead in a culture that champions mentorship, mobility, and bold development.
• Accelerate results with technology. Harness the power of AI and automation to push scientific boundaries and reimagine what's possible in drug discovery.
• Impact through inclusive innovation. Help deliver better science and fairer outcomes by driving inclusive research that reaches more people, in more meaningful ways.
• Turn patient needs into breakthrough science. Drive scientific breakthroughs that start with patient needs – and end in treatments that change lives.