Associate Regulatory Affairs Specialist (18-Month Contract)

About the role

Medtronic, a global healthcare technology company, is hiring an Associate Regulatory Affairs Specialist in Brampton for an 18-month contract. The role supports regulatory submissions, product maintenance and compliance for existing approved products, working closely with regulatory agencies and the international regulatory team.

Key responsibilities

• Prepare document packages and compile materials for regulatory submissions, license renewals and annual registrations
• Recommend changes to labeling, manufacturing, marketing and clinical protocols for regulatory compliance
• Monitor and improve tracking and control systems, and keep up to date with regulatory procedures and changes
• Support Health Canada applications and recommend strategies for early approval
• Manage regulatory submission activities for product maintenance of existing approved products and prepare submissions for product changes
• Review significant submissions with the manager and negotiate submission issues with agency personnel
• Interact directly with regulatory agencies at reviewer level on most projects and products
• Support compliance activities such as manufacturing site registration and audits, and provide local regulatory assessments to the international regulatory team

Required profile

• Bachelor's degree (baccalaureate)
• Nice to have: experience in regulatory affairs through internships, preferably in the medical device industry
• Entry-level individual contributor role with close supervision

What we offer

• Salary range of $64,000 - $80,000
• Flexible benefits package