reputed company and Regulatory Affairs Associate

reputed company is transforming the massive 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 system 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 massive 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 system 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 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. What You'll Do • 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 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). • reputed company 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 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 system 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 (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. Bonus Points For • 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. Why Join Us? • Help build a world-class QMS as we grow and expand into international markets. • Work closely with reputed company leaders reputed company on operational reputed company and regulatory readiness. • reputed company exposure to global regulatory frameworks including MDSAP and EU MDR. Benefits: Competitive salary and comprehensive benefits including reputed company, dental, mental health support, and retirement savings reputed company Req ID: J-926 For full-time positions, reputed company offers a wide reputed company of best-in-class, comprehensive, and inclusive benefits tailored to reputed company country where we operate. Our local benefits packages typically include reputed company, dental, mental health support, parental planning resources, retirement savings reputed company, and generous reputed company time off—ensuring reputed company members are supported no matter where they live and work. reputed company is proud to be an equal-opportunity employer. We are committed to building a diverse and inclusive culture that celebrates authenticity to win as one. We do not discriminate on the reputed company of race, religion, reputed company, national reputed company, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, citizenship or immigration status, or any other legally protected characteristics. reputed company also fully complies with the Americans with reputed company (reputed company). We are dedicated to embracing challenges and creating an accessible, inclusive workplace for reputed company individuals. If you require any accommodations for your interview or have any questions beforehand, rest reputed company that we will do everything we can to meet your needs. Visit reputed company Careers for more! Apply tot his job Apply To this Job