Quality and Regulatory Affairs Associate

Job Description: • Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe. • Compile, format, and maintain technical documentation and submission-ready records in collaboration with cross-functional teams. • Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation. • Coordinate information requests and document retrieval for external reviewers. • Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance. • Support internal and external audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations. • Create, format, route, and maintain controlled documents in the eQMS, including version control, periodic review, and archival of obsolete documents. • Receive, log, review, and route product complaints for investigation; ensure timely, complete, and compliant documentation and closure. • Support analysis and trending of complaints and post-market data; communicate signals and feed learnings into CAPA, risk management, and continuous improvement activities. Requirements: • 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 (or other regulated) industry. • Working knowledge of ISO 13485 and familiarity with MDSAP expectations. • Exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus. • Experience with supporting technical documentation or submissions to a regulatory body. • Strong technical writing, organization, attention to detail, and the ability to manage multiple priorities across teams. Benefits: • Competitive salary and comprehensive benefits including healthcare, dental, mental health support, and retirement savings options. • Local benefits packages typically include healthcare, dental, mental health support, parental planning resources, retirement savings options, and generous paid time off. Apply tot his job