Job Title: Global Regulatory Affairs Device Lead (Associate Director)
📍 Locations:
Morristown, New Jersey, USA
Cambridge, Massachusetts, USA
Framingham, Massachusetts, USA
💰 Salary Range: USD 147,000.00 – 212,333.33
🏢 Company: Sanofi
About Sanofi
At Sanofi, we’re an R&D-driven, AI-powered biopharma company committed to improving lives through groundbreaking science. Our mission is simple yet powerful: to chase the miracles of science to improve people’s lives.
With a strong focus on oncology, rare diseases, immunology, neurology, and vaccines, we combine deep scientific expertise with advanced technologies to deliver innovative healthcare solutions. Sanofi offers a collaborative environment where you can grow your career, expand your expertise, and make a lasting global impact.
About the Role
The Global Regulatory Affairs (GRA) Device Lead – Associate Director will be responsible for developing and executing global regulatory strategies for medical devices, combination products, and IVDs within Sanofi’s diverse portfolio.
You will serve as a key regulatory strategist, ensuring global compliance, leading Health Authority interactions, and driving submissions throughout the product lifecycle—from early development to post-market stages. This highly visible role provides the opportunity to work at the intersection of science, technology, and regulation, directly influencing the success of Sanofi’s innovative therapies worldwide.
Key Responsibilities
Strategic & Regulatory Leadership
Serve as the GRA Device Lead on assigned global project teams (early, late-stage, and marketed products).
Develop and implement innovative, compliant regulatory strategies for standalone and combination medical devices.
Define and lead Health Authority (HA) interaction plans and represent Sanofi in device-related HA meetings.
Identify regulatory risks and acceleration opportunities, proposing risk mitigation strategies collaboratively with Global Regulatory Teams (GRTs).
Ensure consistent regulatory communication and alignment within and across Sanofi teams ("One Sanofi Voice").
Regulatory Operations & Compliance
Lead global submissions and lifecycle management for device and combination product components.
Review and approve design control documentation and device change assessments.
Support regulatory impact evaluations for product modifications or new device technologies.
Maintain compliance with evolving global medical device and IVD regulations.
Support internal audits and due diligence activities for potential business acquisitions.
Cross-functional Collaboration
Liaise with R&D, Manufacturing, Quality, and Commercial teams to ensure unified regulatory direction.
Serve as the regulatory point of contact for device-related discussions and documentation.
Contribute to the creation of submission content plans, document tracking, and regulatory communication.
Support the development of internal device-related regulatory processes and training.
Device Global Regulatory Lead (dGRL) Responsibilities (if assigned)
Act as the single GRA point of contact for assigned medical device or combination product programs.
Lead the Device Global Regulatory Team (GRT) to align strategy, priorities, and execution.
Represent Sanofi in internal governance committees and ensure effective information flow across global teams.
About You
Experience
8+ years of experience in the pharmaceutical, biotechnology, or medical device industry.
5+ years in medical device and/or combination product regulatory affairs, including contributions to major regulatory filings.
Proven experience with Health Authority interactions, submission preparation, and regulatory strategy implementation.
Technical Expertise
In-depth understanding of:
Medical device and IVD development (including design controls).
Clinical development of drug-device combination products.
Manufacturing and quality system regulations.
International regulatory requirements and standards (FDA, EU MDR, ISO, etc.).
Strong analytical skills to synthesize data and assess regulatory risk.
Education
Bachelor’s degree in a scientific or engineering discipline (required).
Graduate degree (MSc, PhD, or equivalent) preferred.
Core Skills
Strategic thinking, risk assessment, and innovative problem-solving.
Strong leadership and team collaboration skills in a matrixed global environment.
Excellent verbal and written communication, including regulatory documentation.
High adaptability in a fast-paced hybrid work environment (60% on-site).
Business acumen and influencing skills across technical and executive levels.
Why Choose Sanofi
🌟 Purpose: Shape the future of global medicine by bringing innovative devices and therapies to life.
🚀 Growth: Advance your career through promotions, international exposure, and leadership opportunities.
💼 Rewards & Benefits:
Comprehensive healthcare, wellness, and prevention programs.
14+ weeks of gender-neutral parental leave.
Competitive compensation and performance-linked rewards.
🌍 Culture: Join a diverse, inclusive, and innovation-driven global organization.
Equal Opportunity Statement
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action Employers committed to creating a culturally diverse workforce.
All qualified applicants will receive consideration without regard to race, color, religion, gender, age, national origin, disability, sexual orientation, veteran status, or any other legally protected characteristic.
Quick Facts
🧭 Department: Global Regulatory Affairs (GRA)
⚙️ Focus Area: Medical Devices, Combination Products, IVDs
🏢 Work Type: Onsite/Hybrid (Morristown, NJ | Cambridge, MA | Framingham, MA)
📊 Job Category: Regulatory Affairs / Device Strategy
💼 Seniority Level: Associate Director
Join Us
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science — where your expertise powers innovation, and your career fuels progress. Help us shape smarter regulatory pathways, deliver better therapies, and make a global difference — together.
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