Gra Device Associate

Sanofi

Cambridge, MA, USA
Base: $122,250.00 - $176,583.33; bonus/equity: not...
Hybrid
Ivd regulatory strategy
Health authority interactions
Device regulatory submissions
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, and optimize product development

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, and optimize product development.
  • 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 provides a thoughtful, well-crafted rewards package, comprehensive health and wellbeing benefits, and structured career paths offering both scientific and leadership advancement opportunities.

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, and optimize product development.

Salary

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

Skills & Requirements

Must-have

  • IVD regulatory strategy
  • Health Authority interactions
  • device regulatory submissions
  • design control deliverables
  • global regulatory strategies

Nice-to-have

  • strategic thinking
  • change agent leadership
  • business acumen
  • AI-powered biopharma
  • patient-centric approach

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