Sanofi US
GRA Device Lead (Associate Director) - Digital Health
Sanofi US, Convent Station, New Jersey, us, 07961
Job Title:
GRA Device Lead (Associate Director) - Digital Health Location:
Cambridge, MA / Morristown, NJ About the Job GRA Device Lead (Associate Director) - Digital Health 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. 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 technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for device and IVD products, leading regulatory efforts in development and post‑marketing stages. As GRA Device Lead in the GRA Device Digital and Diagnostic team you’ll drive global regulatory strategies for medical device and digital health technologies, collaborate with cross‑functional teams, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. The GRA Device Lead role is critical and highly visible; it supports a wide range of digital health technologies (DHTs) from digital biomarkers, wearables, software as a medical device (SaMD), connected devices, and other innovative technologies. Working at the intersection of science and compliance, you will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities, collaborating across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends. About Sanofi: We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives. Our deep understanding of the immune system and innovative pipeline enable us to invent medicines and vaccines that treat and protect millions worldwide. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities
Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products) Provide regulatory guidance and advice to the Global Regulatory Team (GRT) and cross‑functional teams Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements Define device Health Authority interactions plan, lead device‑related Health Authority interactions, and support cross‑functional Health Authority interactions Identify DHT 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 Health Authorities for projects/products in their remit, as needed Participate in development and monitoring of the global regulatory environment and update standards and processes related to device regulations Contribute to a harmonized One Sanofi regulatory voice through participation in device committees and 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 DHTs Accountable for regulatory assessment for DHTs 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 and execution of creative, thoughtful, and robust global regulatory strategies for their products to meet corporate and business objectives Leads the Device GRT, fostering 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 with GRT and cross‑functional partners as appropriate The dGRL is the single GRA point of contact for the DHTs program and represents GRA at the Device Team, the Global Project Team, and internal governance committees About You
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience, contributing to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials to enable the development of digital endpoints and supporting SaMD development; proficiency in preparing regulatory documentation with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of industry standards related to software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability 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 skills Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies Education: 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 Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient‑centric approach Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross‑functional collaboration Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short‑term projects to expand your expertise Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective Enjoy a supportive R&D environment that values work‑life balance, offering flexible working options (60% on-site) and comprehensive well‑being programs Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff and Aff 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, marital status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. The salary range for this position is: $147,000.00 - $212,333.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs. Additional benefits information can be found through the link.
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GRA Device Lead (Associate Director) - Digital Health Location:
Cambridge, MA / Morristown, NJ About the Job GRA Device Lead (Associate Director) - Digital Health 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. 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 technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for device and IVD products, leading regulatory efforts in development and post‑marketing stages. As GRA Device Lead in the GRA Device Digital and Diagnostic team you’ll drive global regulatory strategies for medical device and digital health technologies, collaborate with cross‑functional teams, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide. The GRA Device Lead role is critical and highly visible; it supports a wide range of digital health technologies (DHTs) from digital biomarkers, wearables, software as a medical device (SaMD), connected devices, and other innovative technologies. Working at the intersection of science and compliance, you will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities, collaborating across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends. About Sanofi: We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives. Our deep understanding of the immune system and innovative pipeline enable us to invent medicines and vaccines that treat and protect millions worldwide. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities
Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products) Provide regulatory guidance and advice to the Global Regulatory Team (GRT) and cross‑functional teams Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements Define device Health Authority interactions plan, lead device‑related Health Authority interactions, and support cross‑functional Health Authority interactions Identify DHT 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 Health Authorities for projects/products in their remit, as needed Participate in development and monitoring of the global regulatory environment and update standards and processes related to device regulations Contribute to a harmonized One Sanofi regulatory voice through participation in device committees and 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 DHTs Accountable for regulatory assessment for DHTs 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 and execution of creative, thoughtful, and robust global regulatory strategies for their products to meet corporate and business objectives Leads the Device GRT, fostering 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 with GRT and cross‑functional partners as appropriate The dGRL is the single GRA point of contact for the DHTs program and represents GRA at the Device Team, the Global Project Team, and internal governance committees About You
Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience, contributing to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials to enable the development of digital endpoints and supporting SaMD development; proficiency in preparing regulatory documentation with standard submission processes Technical Knowledge: Understanding of clinical development of medicinal products, device (including design controls), manufacturing processes, and regulatory requirements in major markets; working knowledge of industry standards related to software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability 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 skills Soft Skills: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies Education: 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 Play a crucial role in bringing innovative therapies to millions worldwide, working at the forefront of drug discovery and development with a patient‑centric approach Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross‑functional collaboration Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short‑term projects to expand your expertise Join a workplace that prioritizes diversity, equity, and inclusion, with programs that celebrate every voice and perspective Enjoy a supportive R&D environment that values work‑life balance, offering flexible working options (60% on-site) and comprehensive well‑being programs Influence global regulatory strategies, interact with key health authorities, and stay at the forefront of evolving industry trends and regulations Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff and Aff 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, marital status, sex, gender, sexual orientation, disability, veteran or military status, or any other characteristic protected by law. The salary range for this position is: $147,000.00 - $212,333.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs. Additional benefits information can be found through the link.
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