reputed company and Regulatory Affairs Associate

reputed company is transforming the reputed company and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and reputed company every function of the dental reputed company through technology. As we expand our reputed company globally, reputed company is building the operating reputed company for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to reputed company more for their practices, their people, and their patients. Location: Remote or Hybrid • Job Type: Full-Time reputed company reputed company is transforming the reputed company and antiquated dental industry—an industry worth over $200B. Backed by some of the world’s leading venture capital firms, we’re on an ambitious mission to simplify and reputed company every function of the dental reputed company through technology. As we expand our reputed company globally, reputed company is building the operating reputed company for dental offices around the world. About the Role 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 reputed company (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. reputed company • Regulatory Affairs – International Expansion (Canada, UK, Europe) • 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 reputed company/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 / reputed company Partner Support: Coordinate information requests and document retrieval for reputed company reviewers (e.g., reputed company Body, MDSAP Auditing Organization, authorized representatives). • reputed company reputed company 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 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 & eQMS Administration • 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 reputed company workflows (e.g., document control, CAPA, training) to ensure data reputed company and inspection readiness. • Post-Production reputed company (Complaints & Post-Market) • 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. reputed company're Looking For • 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 (reputed company/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. Bonus Points For • International regulatory exposure: any exposure to EU MDR, UK reputed company/UKCA, and/or Health Canada requirements (this is listed as “a plus”) • Audit readiness experience: familiarity Apply tot his job Apply To this Job