Regulatory Affairs Manager
Core
Manage regulatory affairs deliverables for prosthetic and digital devices across EU, US, and Canada, including product development, lifecycle management, and AI/automation process improvements.
Role type
Senior Regulatory Affairs Manager
Builds
CE/UKCA marking, 510(k), and Health Canada submissions; compliant technical files and post-market surveillance systems
Domain
Medical devices (prosthetics and digital solutions)
Deliverable
production ML models
Required skills
EU/US/Canada medical device regulations, ISO 13485, design control, technical documentation, regulatory strategy, post-market surveillance, software cybersecurity risk management, AI/automation concepts
Preferred skills
Master's degree or PhD, technology/science degree, direct authority interaction, labeling/IFU management, change management
Technologies
STEDs, GSPRCs, UDI systems, eIFU platforms
Responsibilities
Develop and execute regulatory strategies for new devices; manage lifecycle compliance and change requests; support quality management system audits; maintain product registrations and data integrity; provide guidance on global labeling and digital software solutions; identify and implement AI/automation opportunities in regulatory processes
Seniority
Senior, hands-on IC