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 submissions and lifecycle maintenance for international markets (Canada, UK, Europe)
• Maintain and improve quality management system processes to ensure ISO 13485 compliance
• Handle product complaints and assist in post-market surveillance activities

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 in the medical device industry
• Working knowledge of ISO 13485 and familiarity with MDSAP expectations
• Experience with supporting technical documentation or submissions to regulatory bodies
• Exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus