Associate Regulatory Affairs Specialist - 18 months contract
Core
Coordinate regulatory submissions, license renewals, and labeling changes for medical devices to ensure compliance with Health Canada and other agency requirements.
Role type
Associate Regulatory Affairs Specialist (Entry-level IC)
Builds
Regulatory submission packages and documentation for product maintenance and market release
Domain
Medical Devices / Healthcare Technology
Required skills
Regulatory submission preparation, labeling compliance, regulatory strategy, agency interaction, quality system compliance, tracking/control systems
Preferred skills
Medical device industry experience, internship in regulatory affairs
Technologies
Regulatory submission systems, quality management systems
Responsibilities
Direct or perform coordination of document packages for regulatory submissions; compile materials for license renewals and annual registrations; recommend changes for labeling and clinical protocols; monitor regulatory procedures; interact with regulatory agencies at reviewer level; support manufacturing site registration and audits.
Seniority
Entry-level, close supervision