GRA Device Associate- Digital Health

Job Title: GRA Device Associate-Digital Health

Location: Cambridge, MA

The Global Regulatory Affairs (GRA) Device team is a globally diverse group supporting medical device, digital health, and in‑vitro diagnostic products. As a GRA Device Associate in the Digital Health team, you will contribute to global regulatory strategies, collaborate across cross‑functional teams, and support regulatory submissions for digital health technologies.

• 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 sustainable regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements.
• Support device Health Authority interaction plans and related cross‑functional interactions.
• Identify DHT regulatory acceleration opportunities and regulatory risks and propose risk mitigations.
• Identify issues that impact submission timelines; ensure communication, resolution, and escalation as needed.
• Support global filing and lifecycle management activities for device submissions and 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 remit.
• Support operational and compliance activities for assigned deliverables; develop and 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.

• 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 contributing 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, fluent in English.
• Capability to manage multiple projects in a fast‑paced, hybrid work environment (60% on‑site).

• Preferred Qualifications
• Familiarity with implementing device regulatory strategies to support DHT integration into clinical trials and 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 of technical/industry standards related to software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability.
• Ability to synthesize and critically analyze data from multiple sources.

Salary range: $122,250 – $176,583.

48‑week parental leave, comprehensive health and wellness programs, and a competitive compensation package.

Sanofi and its U.S. affiliates are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, veteran status, or other characteristics protected by law.