Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

• Support regulatory registration efforts for medical devices in global healthcare spin-offs
• Evaluate product changes for rebranding and their impact on existing licenses with Health Canada
• Update technical documentation and coordinate with international regulatory teams for timely submissions

Required Qualifications

• Bachelor's Degree or higher in Biology, Chemistry, Pharmacology, Biochemistry, or a related field
• 2-3 years of experience in regulatory affairs within the medical device industry
• Direct experience with submissions to Health Canada
• Proven ability to author technical documentation and support international registrations