GRA Device Associate

Role Summary

Location: Cambridge, MA / Morristown, NJ / Washington, DC. The GRA Device Associate contributes to global regulatory strategies for in vitro diagnostic technologies, collaborating with cross-functional teams to navigate regulatory landscapes, optimize product development, and influence product approvals through strategic negotiations with health authorities worldwide. This role supports a range of diagnostics within the Sanofi portfolio and interfaces with R&D, Device, Manufacturing, and Quality teams to prepare regulatory submissions and ensure lifecycle compliance.

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 innovative and sustainable medical device 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, and propose thoughtful risk mitigations in collaboration with the GRT
• Identify issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
• Support global filing and lifecycle management activities for device submissions and device aspects of medicinal product submissions
• Liaises with device, clinical, manufacturing, commercial, and other internal business 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 a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
• Support operational and compliance activities for assigned deliverables, develop and execute regulatory submission planning activities, including submission content plans, submission tracking, communication and document management
• Contribute to internal regulatory processes and procedures for IVD

Qualifications

• Experience: 6+ years of relevant pharmaceutical/biotechnology/medical device industry experience with 3+ years of relevant IVD 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, IVD development (including design controls), manufacturing processes, and regulatory requirements in major markets. Working knowledge with technical/industry standards related to global IVD regulations (US FDA IDE/PMA, EU IVDR), technical documentation, ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies. 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: Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies
• Communication: Strong written and verbal communication and influencing skills, with fluency in English.
• Adaptability: ability to manage multiple projects in a fast-paced, hybrid work environment, with openness to learning and growth.

Education

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

Additional Requirements

• Hybrid work environment with approximately 60% on-site