GRA Device Associate

Role Summary

GRA Device Associate supporting global regulatory strategies for in-vitro diagnostic technologies within the Sanofi portfolio, collaborating with cross-functional teams to navigate regulatory landscapes and influence product approvals.

Responsibilities

• Partner with the Device Regulatory Lead on assigned projects
• Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams
• Contribute to and execute regulatory strategies covering IVD elements
• Contribute to device Health Authority interactions plan, lead device related health authority interactions and support cross-functional health authority interactions
• Identify IVD regulatory acceleration opportunities and regulatory risks, proposing risk mitigations with the GRT
• Identify issues and opportunities that impact submissions timelines; communicate, resolve and escalate as needed
• Support global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal partners to enable successful regulatory outcomes
• Prepare and review design control deliverables
• Contribute to product development and lifecycle management planning; provide regulatory impact assessments for proposed product changes
• May serve as regional/local regulatory lead and contact with Health Authorities as needed
• Support regulatory submission planning activities, including content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for IVD

Qualifications

• Experience: 6+ years in pharmaceutical/biotechnology/medical device with 3+ years in IVD regulatory experience and regulatory filings; experience responding to Health Authority questions
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes
• Technical Knowledge: Understanding of clinical development, IVD development (design controls), manufacturing processes, regulatory requirements in major markets; knowledge of US FDA IDE/PMA, EU IVDR; ISO 13485/15189; CLIA; lab developed test; clinical performance studies; ability to synthesize data from multiple sources
• Collaboration Skills: Ability to work in a matrix environment with R&D, Device, Manufacturing, and Quality teams; strong leadership and negotiation skills
• Soft Skills: Strategic thinking, initiative, change leadership, risk assessment; integrate business objectives into project strategies
• Education: Bachelor's in scientific or engineering field; graduate degree preferred
• Communication: Strong written and verbal skills; fluent in English
• Adaptability: Ability to manage multiple projects in a fast-paced hybrid environment (60% on-site)