Sanofi · 1 day ago
Global Regulatory Affairs Device Lead (Associate Director)
Framingham, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
8+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Global Regulatory Affairs Device Lead will drive global regulatory strategies for medical device and combination products, collaborating with cross-functional teams to navigate complex regulatory landscapes and influence product approvals.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Serve as GRA Device Lead on assigned project teams (early phase, late stage and marketed products)
Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elements
Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
Identifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRT
Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
Lead 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, review and approve 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 device Health Authorities for projects/products in their remit, as needed
Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document management
Contribute to internal regulatory processes and procedures for medical devices
Accountable for regulatory assessment for medical devices Due Diligence activities as applicable
May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the additional responsibilities:
The dGRL is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in order to meet corporate and business objectives
Leads the Device GRT, for fosters team performance by aligning team on mission, prioritization, objectives and setting clear expectations for the device regulatory strategy, including a global labeling strategy
Ensures alignment and communication internally and externally as “one GRA voice” to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate
The dGRL is the single GRA point of contact for the medical device program and represents GRA at the Device Team, the Global Project Team, and internal governance committees
Qualification
Required
8+ years of relevant pharmaceutical/biotechnology/medical device industry experience
5+ years of medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
Experience responding to Health Authority questions
Experience preparing regulatory documentation and familiarity with 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 with technical/industry standards related to medical devices
Ability to synthesize and critically analyze data from multiple sources
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
Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency
Bachelor's degree in a scientific or engineering discipline
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
Graduate degree preferred
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-08
2026-01-08
Company data provided by crunchbase