GRA Device Lead (Associate Director) - Digital Health

* 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 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* Identifies DHTs 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 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 DHTs* Accountable for regulatory assessment for DHTs Due Diligence activities as applicable.**Experience:** 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.**Regulatory Expertise:** Ability to develop device regulatory strategyProficiency in preparing regulatory documentation**Technical Knowledge:** Understanding of device (including design controls), manufacturing processes, and regulatory requirements in major markets.

Working knowledge with technical/industry standards related to e.g., software development lifecycle, design controls, labeling, software documentation, risk management, clinical evaluations, and usability.

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 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.* 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. #J-18808-Ljbffr