GRA Device Associate

Role Summary

GRA Device Associate based in Cambridge, MA / Morristown, NJ / Washington DC. Support global regulatory strategies for medical device and IVD products within the Sanofi portfolio, collaborating across R&D, Device, Manufacturing, and Quality teams to prepare regulatory submissions and navigate health authority interactions.

• 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 submissions timelines; ensures appropriate communication, resolution and/or escalation as needed
• Support 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 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
• 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 IVD

• 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
• 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
• 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:
  Ability to manage multiple projects in fast-paced, hybrid work environment (60% on-site)

• Regulatory strategy development
• Health Authority engagement
• IVD regulatory frameworks (FDA, EU IVDR)
• Design controls and technical documentation
• Cross-functional collaboration
• Regulatory submissions and lifecycle management

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

• Hybrid work environment with approximately 60% on-site Presence