GRA Device Lead (Associate Director)

Role Summary

GRA Device Lead (Associate Director) responsible for driving global regulatory strategies for medical device and combination products, collaborating with cross-functional teams to navigate regulatory landscapes, and influencing product approvals through interactions with health authorities worldwide.

Responsibilities

• Serve as GRA Device Lead 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 combination products and delivery systems (device elements)
• Define device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify medical device regulatory acceleration opportunities and regulatory risks, and propose 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 medical device 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 MD/IVD
• Accountable for regulatory assessment for MD/IVD Due Diligence activities as applicable

Qualifications

• Experience: 8+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 5+ years of relevant medical device and/or combination product regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes.
• Technical Knowledge: Understanding of clinical development of medicinal products, device development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to injection devices. 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: 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).

Skills

• Regulatory strategy development
• Health Authority negotiations
• Regulatory submissions and lifecycle management
• Design controls and device development knowledge
• Cross-functional collaboration
• Risk assessment and mitigation

Education

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