Document Control Specialist - Remote

Overview

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.

In Short

• Own and manage the lifecycle of controlled quality documents (SOPs, Work Instructions, Forms, Records, etc.)
• Maintain document control processes that align with ISO 13485, MDSAP, and FDA 21 CFR Part 820
• Support future expansion of the QMS to meet EU MDR/IVDR documentation requirements (e.g., Technical Files, DHFs)
• Control issuance, revision, approval, and obsolescence processes for quality documentation across multiple sites
• Support internal, supplier, and regulatory audits by ensuring document readiness, version control, and retrieval
• Ensure training records and document change controls are traceable and compliant with applicable standards
• Partner with cross-functional teams to implement changes, release documents, and ensure timely training
• Assist the QMS Manager in harmonizing site-level documentation and driving best practices in documentation structure
• Maintain documentation logs, training matrices, and controlled document access (physical and digital)

Requirements

• 3+ years of document control experience in the medical device, biotech, or pharma industry
• Working knowledge of ISO 13485, MDSAP, and FDA 21 CFR Part 820
• Familiarity with document requirements related to EU MDR/IVDR or willingness to learn
• Experience with eQMS platforms or structured document management systems (e.g., MasterControl, Veeva, Greenlight Guru, or Google Drive-based control systems)
• Strong attention to detail, organizational, and communication skills
• Ability to work independently across departments and time zones
• Proficiency in Google Workspace or Microsoft Office

Benefits

• Help build a world-class QMS as we grow and expand into international markets
• Work closely with experienced leaders focused on operational excellence and regulatory readiness
• Gain exposure to global regulatory frameworks including MDSAP and EU MDR
• Competitive salary, benefits, and career development opportunities