Quality and Regulatory Affairs Associate

About the Role:

• Regulatory Execution: Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe.
• Technical Documentation: Compile, format, and maintain technical documentation and submission-ready records.
• Regulatory Intelligence: Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation as needed.

Quality System Compliance (ISO 13485 & MDSAP):

• QMS Support: Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance.
• Audit Readiness & Support: Support internal and external audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations.
• Training & Records: Support training assignments, effectiveness documentation, and maintenance of compliance records in the eQMS.

Post-Production Quality (Complaints & Post-Market):

• Complaint Handling: Receive, log, review, and route product complaints for investigation; ensure timely, complete, and compliant documentation and closure.
• Escalation & Reporting Support: Support evaluation of complaint severity and potential reportability; assist with documentation for vigilance, safety reporting, and field actions per applicable regulations and procedures.
• Trending: Support analysis and trending of complaints and post-market data.