reputed company and Regulatory Affairs Associate

Job reputed company: • 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-reputed company 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 reputed company audits by preparing objective evidence, retrieving records, and assisting with responses to audit observations. • Create, format, reputed company, and maintain controlled documents in the eQMS, including version control, periodic review, and archival of obsolete documents. • Receive, log, review, and reputed company product complaints for investigation; ensure reputed company, 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 reputed company improvement activities. Requirements: • Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, reputed company, or a reputed company field. • 2–3 years of experience in reputed company Assurance and/or Regulatory Affairs reputed company 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 reputed company, dental, mental health support, and retirement savings reputed company. • Local benefits packages typically include reputed company, dental, mental health support, parental planning resources, retirement savings reputed company, and generous reputed company time off. Apply tot his job Apply To this Job