Sanofi
Global Regulatory Affairs Device Lead (Associate Director)
Sanofi, Cambridge, Massachusetts, us, 02238
Job title: Global Regulatory Affairs Device Lead (Associate Director)Location: Morristown, NJ or Cambridge, MA or Framingham, MA About the JobAre 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 maintains 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.
As GRA Device Lead in the GRA Device, General Medicine and Vaccine Medical Device and Combination Product team 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. Ready to get started? The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of combination products, from pre-filled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide About Sanofi:We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Main ResponsibilitiesServe 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 teamsDevelop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elementsDefine device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactionsIdentifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRTIdentify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as neededLead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissionsLiaises 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 changesMay serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as neededParticipates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulationsContributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forumsSupports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document managementContribute to internal regulatory processes and procedures for medical devicesAccountable for regulatory assessment for medical devices Due Diligence activities as applicableMay 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 strategyEnsures 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 About YouThis position requires an experienced regulatory affairs professional with familiarity with international submissions from within a global healthcare organization.
You will have had experience in large organizations given the need to be able to interact across the Sanofi organization. Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 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.Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processesTechnical Knowledge: 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.Collaboration 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 skillsSoft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategiesEducation: Bachelor's degree in a scientific or engineering discipline.
Graduate degree preferred.Communication: Strong written and verbal communication and influencing skills, with fluency in English.Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth. Why Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.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; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SA #LI-SA
#LI-Onsite#vhd
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.
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 maintains 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.
As GRA Device Lead in the GRA Device, General Medicine and Vaccine Medical Device and Combination Product team 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. Ready to get started? The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of combination products, from pre-filled syringes, pen injectors, autoinjectors, large volume devices and other innovative technologies. Working at the intersection of science and compliance, you'll develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities. You'll collaborate across R&D, Device, Manufacturing, and Quality teams while preparing high-quality regulatory submissions, managing compliance, and anticipating regulatory trends—all contributing directly to bringing innovative therapies to patients worldwide About Sanofi:We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world and are supported and enhanced through our diverse portfolio of medical device and diagnostic products. Together, we chase the miracles of science to improve people’s lives.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Main ResponsibilitiesServe 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 teamsDevelop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part of combination products elementsDefine device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactionsIdentifies medical device regulatory acceleration opportunities and regulatory risks, and proposes thoughtful risk mitigations in collaboration with the GRTIdentify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as neededLead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissionsLiaises 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 changesMay serve as a regional/local regulatory lead and point of contact with medical device Health Authorities for projects/products in their remit, as neededParticipates in the development and monitoring of the global regulatory environment and updating of standards and processes related to device regulationsContributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate device committees, forumsSupports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, communication and document managementContribute to internal regulatory processes and procedures for medical devicesAccountable for regulatory assessment for medical devices Due Diligence activities as applicableMay 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 strategyEnsures 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 About YouThis position requires an experienced regulatory affairs professional with familiarity with international submissions from within a global healthcare organization.
You will have had experience in large organizations given the need to be able to interact across the Sanofi organization. Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 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.Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processesTechnical Knowledge: 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.Collaboration 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 skillsSoft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategiesEducation: Bachelor's degree in a scientific or engineering discipline.
Graduate degree preferred.Communication: Strong written and verbal communication and influencing skills, with fluency in English.Adaptability: Capability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site), with openness to learning and growth. Why Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.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; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#GD-SA #LI-SA
#LI-Onsite#vhd
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.