GRA Device Lead; Associate Director - Digital Health

Position: 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.
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* 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 strategy

Proficiency 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
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* Soft Skills:

** Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
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* 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…