Gra Device Lead (associate Director) - Digital Health
Sanofi UK
Cambridge, MA, US
$148,500.00 - $214,500.00; not specified; not spec...
Hybrid
Global regulatory strategies for device
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.
Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy.
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 strategies for device
Digital health technologies (DHTs)
Software as a Medical Device (SaMD)
Health Authority interactions
Device regulatory strategy development
Cross-functional team collaboration
Nice-to-have
AI-powered biopharma company
Patient-centric approach
Work-life balance
Career growth opportunities
Key Requirements
8+ years pharmaceutical/biotechnology/medical device industry experience
5+ years Device/DHTs regulatory experience
Experience responding to Health Authority questions
Bachelor's degree in scientific or engineering discipline