Sanofi
Global Regulatory Affairs Device Lead (Associate Director)
Sanofi, Cambridge, Massachusetts, us, 02140
Global Regulatory Affairs Device Lead (Associate Director)
Base pay range: $147,000.00/yr - $212,333.33/yr
Location:
Morristown, NJ or Cambridge, MA or Framingham, MA
About The Job:
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post‑marketing stages. The team creates and maintain strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.
Role Overview:
As GRA Device Lead you’ll drive global regulatory strategies for medical device and combination products, collaborate with cross‑functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. You will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You will collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends.
Main 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
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
Lead 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, 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
Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
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 medical devices
Accountable for regulatory assessment for medical devices Due Diligence activities as applicable
Qualifications
8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience; 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 of technical/industry standards related to medical devices.
Ability to synthesize and critically analyze data from multiple sources.
Effective matrix collaboration across R&D, Device, Manufacturing, and Quality teams; strong business acumen, influencing and persuasive negotiation skills.
Strategic thinking, initiative, change agency leadership and risk assessment proficiency.
Bachelor’s degree in a scientific or engineering discipline; graduate degree preferred.
Strong written and verbal communication and influencing skills; fluency in English.
Capability to manage multiple projects in a fast‑paced, hybrid work environment (60% on‑site); openness to learning and growth.
Benefits
Generous rewards package that recognizes your contribution and amplifies your impact.
Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave.
Opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Equal Opportunity Statement:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; sexual orientation; disability; veteran or military status; domestic violence victim status; atypical cellular or genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Application:
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
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Location:
Morristown, NJ or Cambridge, MA or Framingham, MA
About The Job:
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic (IVD) products within the Sanofi portfolio of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. Our department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team is accountable for developing and implementing global regulatory strategies for device and IVD products, intended to be used alone or in combination with a drug product, leading regulatory efforts in the development and post‑marketing stages. The team creates and maintain strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country Regulatory Groups, Technical and Quality Groups within R&D and Manufacturing & Supply, Regulatory Health Authorities, and others.
Role Overview:
As GRA Device Lead you’ll drive global regulatory strategies for medical device and combination products, collaborate with cross‑functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. You will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You will collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends.
Main 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
Identify medical device regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
Lead 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, 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
Participate in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulations
Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forums
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 medical devices
Accountable for regulatory assessment for medical devices Due Diligence activities as applicable
Qualifications
8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of medical device and/or combination product regulatory experience; 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 of technical/industry standards related to medical devices.
Ability to synthesize and critically analyze data from multiple sources.
Effective matrix collaboration across R&D, Device, Manufacturing, and Quality teams; strong business acumen, influencing and persuasive negotiation skills.
Strategic thinking, initiative, change agency leadership and risk assessment proficiency.
Bachelor’s degree in a scientific or engineering discipline; graduate degree preferred.
Strong written and verbal communication and influencing skills; fluency in English.
Capability to manage multiple projects in a fast‑paced, hybrid work environment (60% on‑site); openness to learning and growth.
Benefits
Generous rewards package that recognizes your contribution and amplifies your impact.
Health and wellbeing benefits including high‑quality healthcare, prevention and wellness programs and at least 14 weeks’ gender‑neutral parental leave.
Opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Equal Opportunity Statement:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; sexual orientation; disability; veteran or military status; domestic violence victim status; atypical cellular or genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Application:
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
#J-18808-Ljbffr