GRA Device Associate- Digital Health
Core
Develop and implement global regulatory strategies for medical device and digital health technologies (SaMD, wearables, digital biomarkers) to ensure compliance and optimize product approval pathways.
Role type
Senior Regulatory Affairs Associate (Medical Devices/Digital Health)
Builds
Regulatory submissions and lifecycle management for digital health and medical device products
Domain
Biopharma / Medical Devices / Digital Health
Deliverable
regulatory submissions
Required skills
regulatory strategy development, risk assessment, health authority interaction, submission planning, design control deliverables, lifecycle management, cross-functional collaboration
Preferred skills
digital health technology implementation, clinical trial regulatory support, software development lifecycle knowledge, risk management, usability evaluation
Technologies
SaMD, wearables, digital biomarkers
Responsibilities
Partner with Device Regulatory Lead on assigned projects; Provide regulatory guidance to cross-functional teams; Execute innovative medical device regulatory strategies; Support health authority interactions; Identify regulatory acceleration opportunities and risks; Support global filing and lifecycle management; Prepare and review design control deliverables; Contribute to product development planning and regulatory impact assessments.
Seniority
Mid-Senior, hands-on IC
