Gra Device Lead (associate Director) - Digital Health

Sanofi

Cambridge, MA, US
$148,500.00 - $214,500.00; not specified; not spec...
Hybrid
Global regulatory affairs
Digital health technologies (dhts)
Software as a medical device (samd)
The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and other innovative technologies

Job Summary

  • The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and other innovative technologies.
  • Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products) and provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional teams.
  • Benefit from structured career paths offering both scientific and leadership advancement opportunities, including bold moves and short-term projects to expand your expertise.

Matching Summary

The GRA Device Lead role is a critical and highly visible position offers the opportunity to support a wide range of digital health technologies (DHTs), from digital biomarkers, wearables, software as a medical device (SaMD), connected devices and other innovative technologies.

Salary

$148,500.00 - $214,500.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Global Regulatory Affairs
  • Digital Health Technologies (DHTs)
  • Software as a Medical Device (SaMD)
  • Regulatory strategy development
  • Health Authority interactions

Nice-to-have

  • AI-powered biopharma company
  • Cross-functional collaboration
  • Patient-centric approach
  • Adaptability and learning
  • Work-life balance

Key Requirements

  • 8+ years of relevant industry experience
  • 5+ years of Device/DHTs regulatory experience
  • Bachelor's degree in scientific or engineering discipline
  • Experience with international submissions
  • Experience responding to Health Authority questions

Work Rights

Not specified

Tailored Resume

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