Regulatory Affairs Specialist - 18 months Contract

Medtronic seeks a Regulatory Affairs Specialist for an 18-month contract position in Brampton, Ontario. The role involves coordinating regulatory submissions, managing product compliance documentation, and liaising with Health Canada and international regulatory agencies to support medical device approvals and market maintenance.

Responsibilities

• Coordinate and prepare regulatory submission document packages for Health Canada and internal audits
• Compile materials for license renewals, registrations, and product change submissions
• Recommend labeling and manufacturing modifications to ensure regulatory compliance
• Interact with regulatory agencies on submissions and resolve compliance questions
• Support marketed products through review of labeling, promotional materials, and change documentation

Requirements

• Bachelor's degree required
• Minimum 2 years regulatory affairs experience, preferably medical devices
• Advanced degree acceptable with no prior medical device industry experience
• Knowledge of Health Canada and international regulatory requirements
• Ability to assess labeling, design, and manufacturing changes for regulatory impact

Compensation: $73,520 - $91,900