GRA Device Associate - Medical Devices and Combination Products; Senior Manager

Job Title:

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

Location:

Morristown, NJ

The Global Regulatory Affairs (GRA) Device team supports medical devices, combination products, digital health, and in‑vitro diagnostics across Sanofi. The GRA Device Associate will contribute to global regulatory strategies, collaborate cross‑functionally, and influence product approvals through strategic negotiations.

• Partner with the Device Regulatory Lead on assigned projects.
• Provide regulatory guidance to GRA and cross‑functional teams.
• Execute strategies covering stand‑alone and combination device elements.
• Contribute to device Health Authority interaction plans and support cross‑functional interactions.
• Identify acceleration opportunities and risk mitigations.
• Ensure timely communication, resolution, and escalation of issues impacting submissions.
• Support global filing and lifecycle management for device submissions and medicinal product aspects.
• Liaise with device, clinical, manufacturing, commercial, and other stakeholders to ensure regulatory success.
• Prepare and review design‑control deliverables.
• Contribute to product development and lifecycle planning.
• Provide regulatory impact assessments for proposed product changes.
• Act as regional/local regulatory lead for device Health Authorities when required.
• Develop, execute, and track regulatory submission planning activities.
• Contribute to internal regulatory processes and procedures for device/IVD.

• Education:
  
  Bachelor’s degree in a scientific or engineering discipline (Master’s or PhD preferred).
• Experience:
  
  6+ years in pharmaceutical, biotechnology, or medical device industry.
• Regulatory: 3+ years of experience in CMC, device, or combination product strategy with filings.
• Experience responding to Health Authority questions.
• Skills:
  
  Implementation of device regulatory strategies, preparation of regulatory documentation, knowledge of drug and device development, and change controls.
• Business acumen, leadership, influencing, negotiation, strategic thinking, initiative, change‑agent and risk‑assessment expertise.
• Strong written and verbal communication in English.

• Competitive salary: $122,250 – $176,583.
• Health coverage, prevention and wellness programs.
• At least 14 weeks of gender‑neutral parental leave.
• Opportunities for career growth domestically and internationally.

Sanofi Inc. and its U.S. affiliates are equal‑opportunity and affirmative‑action employers committed to a diverse workforce. All qualified applicants will receive consideration without regard to protected categories.