GRA Device Lead (Associate Director) - Digital Health

Role Summary

The GRA Device Lead (Associate Director) - Digital Health drives global regulatory strategies for medical device and digital health technologies, collaborating with cross-functional teams to navigate complex regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through strategic negotiations with health authorities worldwide. This role focuses on a wide range of digital health technologies, including digital biomarkers, wearables, SaMD, and connected devices, developing device strategies, conducting risk assessments, and serving as the primary liaison with regulatory authorities.

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 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

Qualifications

• 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 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 with technical/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
• Soft Skills: Strategic thinking, initiative, change agent leadership and risk assessment proficiency, 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)

Education

• Bachelor's degree in a scientific or engineering discipline. Graduate degree preferred.