Dandy · 6 days ago
Quality and Regulatory Affairs Associate
United States
Full-time
Remote
Entry, Mid Level
$75K/yr - $86K/yr
2+ years expDandy is transforming the dental industry through technology and is seeking a Quality and Regulatory Affairs Associate to join their team. In this role, you will execute regulatory requirements for international markets and support the Quality Management System, contributing to post-production quality activities and ensuring compliance with industry standards.
Artificial Intelligence (AI)CADDentalHealth CareIndustrial AutomationLogisticsManufacturingSoftware
Responsibilities
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
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field
2–3 years of experience in Quality Assurance and/or Regulatory Affairs within 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
Preferred
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
Healthcare
Dental
Mental health support
Retirement savings options
Parental planning resources
Generous paid time off
Company
Dandy
More than a dental lab—Dandy is a tech-powered, end-to-end solution delivering high-quality, customized restorations at scale.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
GreenoaksPrimary Venture Partners
2025-05-02Series D
2022-08-17Series C
2022-01-20Series B
Leadership Team
Daniel Hanover
Co-Founder, Chief Executive Officer, Chief Technology Officer
Toni Oloko
Co-Founder
Recent News
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