Dozee

Compliance

• Set the regulatory roadmap and define U.S. regulatory pathways for new hardware and software features
• Lead FDA submissions and respond to FDA correspondence
• Own FDA inspections and audits from preparation through completion
• Structure and implement the quality management system
• Conduct or oversee an independent assessment of the current regulatory and quality structure
• Own and implement CAPA processes
• Instrument QMS under 21 CFR 820 and ISO 13485, including design controls and document control
• Direct and audit compliance work performed by distributed engineering and QA teams, including offshore teams
• Own SOC 2 Type II and HIPAA compliance programs
• Manage post-market surveillance, adverse event reporting, and complaint handling
• Report regulatory and quality health to the CEO and an independent board member
• Advise Product and Engineering on design changes, new features, and hardware revisions
• Align documentation and quality systems with relevant international standards
• Continue CE compliance and enable other international regulatory clearances
• Report submission status, audit readiness, and certification timelines to leadership
• Nurture and build the regulatory affairs specialists team

Head of Global Regulatory and Quality Affairs