GRA Device Lead (Associate Director) - Digital Health

Role Summary

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 regulatory landscapes, optimize product development and manufacturing processes, and influence product approvals through negotiations with health authorities worldwide.

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
• May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes additional responsibilities: fully accountable decision maker for global regulatory strategies; leads the Device GRT; ensures alignment and communication as “one GRA voice”; represents GRA at governance committees

Qualifications

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of Device/DHTs regulatory experience and experience in regulatory filings and strategy development
• Regulatory Expertise: Ability to develop device regulatory strategy to support implementing DHTs into clinical trials and SaMD development; proficiency in regulatory documentation and standard submission processes
• Technical Knowledge: Understanding of clinical development, device design controls, manufacturing processes, and regulatory requirements in major markets; familiarity with software development lifecycle, labeling, risk management, clinical evaluations, and usability
• Collaboration Skills: Ability to work in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership, influence and negotiation skills
• Soft Skills: Strategic thinking, initiative, change leadership, and risk assessment capabilities
• Education: Bachelor's degree in a scientific or engineering discipline; graduate degree preferred
• Communication: Strong written and verbal communication and influencing skills; fluent in English
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid environment (60% on-site)

Education

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

Additional Requirements

• Hybrid work environment (60% on-site)