Quality and Regulatory Affairs Associate
Dandy 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 modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams with technology, innovation, and world-class support to achieve more for their practices, their people, and their patients. Location: Remote or Hybrid
- Job Type: Full-Time
About Us
Dandy 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 modernize every function of the dental practice through technology. As we expand our reach globally, Dandy is building the operating system for dental offices around the world.
About the Role
Dandy is hiring a detail-oriented Quality and Regulatory Affairs Associate to join our rapidly growing venture-backed company. The Quality team owns Quality and Compliance. In this role, you’ll help execute regulatory requirements for Canada, the UK, and Europe, while supporting an ISO 13485-compliant Quality Management System (QMS) and MDSAP readiness. You will also contribute to post-production quality activities such as post - market surveillance, CAPA support, and document control within an electronic QMS (eQMS). The role is an exciting opportunity to implement and improve quality 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-ready 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.
- Notified Body / External Partner Support: Coordinate information requests and document retrieval for external reviewers (e.g., Notified Body, MDSAP Auditing Organization, authorized representatives).
- Quality 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 internal and external 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, route, 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 access, templates, and day-to-day system workflows (e.g., document control, CAPA, training) to ensure data integrity and inspection readiness.
- Post-Production Quality (Complaints & Post-Market)
- Complaint Handling: Receive, log, review, and route product complaints for investigation; ensure timely, 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 continuous improvement activities.
What We're Looking For
- Education: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
- Experience: 2–3 years of experience in Quality Assurance and/or Regulatory Affairs within 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.
- Core 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