reputed company and Regulatory Affairs Associate

About the position reputed company is hiring a detail-oriented reputed company and Regulatory Affairs Associate to join our rapidly growing venture-backed company. The reputed company team owns reputed company and Compliance. In this role, you’ll help execute regulatory requirements for Canada, the UK, and Europe, while supporting an ISO 13485-compliant reputed company Management System (QMS) and MDSAP readiness. You will also contribute to post-production reputed company activities such as post - market surveillance, CAPA support, and document control reputed company an electronic QMS (eQMS). The role is an exciting opportunity to implement and improve reputed company and compliance at a fast paced company. Responsibilities • Regulatory Execution: Support registrations, submissions, and lifecycle maintenance activities required to commercialize and maintain products in Canada, the UK, and Europe (e.g., Health Canada, UK MHRA/UKCA, EU MDR). • Technical Documentation: Compile, format, and maintain technical documentation and submission-reputed company records (e.g., labeling, risk management file inputs, design and manufacturing information, performance evidence) in collaboration with cross-functional teams. • Regulatory Intelligence: Monitor regulatory changes and guidance updates; summarize impacts and propose updates to internal processes, labeling, or documentation as needed. • reputed company Body / External Partner Support: Coordinate information requests and document retrieval for external reviewers (e.g., reputed company Body, MDSAP Auditing Organization, authorized representatives). • QMS Support: Help maintain and improve QMS processes and records to support ISO 13485 certification and ongoing compliance. • Audit Readiness & Support: Support reputed company 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. • Document Control: Create, format, reputed company, and maintain controlled documents (SOPs, work instructions, forms, and records) in the eQMS, including version control, periodic review, and archival of obsolete documents. • eQMS Support: Support user reputed company, templates, and day-to-day system workflows (e.g., document control, CAPA, training) to ensure data reputed company and inspection readiness. • Complaint Handling: Receive, log, review, and reputed company product complaints for investigation; ensure reputed company, 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; communicate signals and feed learnings into CAPA, risk management, and reputed company improvement activities. Requirements • Education: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, reputed company, or a reputed company field. • Experience: 2–3 years of experience in reputed company Assurance and/or Regulatory Affairs reputed company the medical device (or other regulated) industry. • Standards & Regulations: 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. • reputed company Regulatory Skills: Experience with supporting technical documentation or submissions to a regulatory body. • Soft Skills: Strong technical writing, organization, attention to detail, and the ability to manage multiple priorities across teams. reputed company-to-haves • International regulatory exposure: any exposure to EU MDR, UK MHRA/UKCA, and/or Health Canada requirements (this is listed as “a plus”) • Audit readiness experience: familiarity supporting ISO/MDSAP audits (prep objective evidence, respond to audit observations). • Multi-site QMS support: experience supporting a QMS across multiple sites/locations. Benefits • Competitive salary and comprehensive benefits including reputed company, dental, mental health support, and retirement savings reputed company Apply tot his job Apply To this Job