Quality and Regulatory Associate

Job Summary

A company is looking for a Quality and Regulatory Affairs Associate to support regulatory requirements and quality management systems.

Key Responsibilities

• Support regulatory execution for product registrations and lifecycle maintenance in Canada, the UK, and Europe
• Maintain and improve quality management system processes and records for ISO 13485 compliance
• Handle product complaints and assist in the analysis and trending of post-market data

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field
• 2-3 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry
• Working knowledge of ISO 13485 and familiarity with MDSAP expectations
• Experience supporting technical documentation or submissions to a regulatory body
• Exposure to EU MDR, UK MHRA/UKCA, and/or Health Canada requirements is a plus