Gra Device Associate

Sanrafaelvet

Cambridge, MA, US
Base: $122,250.00 - $176,583.33; bonus/equity: not...
Hybrid
Ivd regulatory experience
Regulatory filings
Health authority interactions
The GRA Device Associate will contribute to global regulatory strategies for in-vitro diagnostic technologies, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide

Job Summary

  • The GRA Device Associate will contribute to global regulatory strategies for in-vitro diagnostic technologies, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide.
  • The role offers the opportunity to support a wide range of diagnostics, including diagnostics used in medicinal product clinical trials, diagnostic reagents, and companion and complimentary diagnostics.
  • Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth, with a supportive, future-focused team and endless opportunities to grow your talent.

Matching Summary

The GRA Device Associate will contribute to global regulatory strategies for in-vitro diagnostic technologies, collaborate with cross-functional teams to navigate complex regulatory landscapes, optimize product development, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide.

Salary

Base: $122,250.00 - $176,583.33; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • IVD regulatory experience
  • regulatory filings
  • Health Authority interactions
  • design control deliverables
  • global regulatory strategies

Nice-to-have

  • AI-powered biopharma
  • patient-centric approach
  • cross-functional collaboration
  • structured career paths
  • work-life balance

Key Requirements

  • 6+ years industry experience
  • 3+ years IVD regulatory experience
  • Bachelor's degree in science/engineering
  • Experience responding to Health Authority questions
  • Working knowledge of global IVD regulations

Work Rights

Not specified

Tailored Resume

Cover Letter