Head of Global Regulatory and Quality Affairs

Dozee

. Set the regulatory roadmap and define U.S.

Posted 9/22/2026full-timeHouston • Texas • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in U.S. medical device regulatory affairs, including FDA submissions, quality management systems, and compliance with 21 CFR 820 and ISO 13485. Proven ability to lead regulatory initiatives, manage audits, and ensure adherence to international standards.

Highest-signal resume keywords

FDA SubmissionsQuality Management System (QMS)21 CFR 820 ComplianceISO 13485 ExperienceSOC 2 Type II Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory PathwaysPost-Market SurveillanceAdverse Event ReportingDevice Classification510(k) SubmissionsDe Novo SubmissionsPMA SubmissionsCAPA ProcessesDocument ControlAudit Management

Soft Skills

LeadershipTeam BuildingCommunicationProblem SolvingCollaboration

Certifications & Qualifications

Regulatory Affairs Certification (RAC)ISO 13485 Lead Auditor TrainingAAMI Training on 21 CFR 820 / ISO 14971

Industry Keywords

Medical Device Regulatory AffairsFDA InspectionsQuality Assurance (QA)HIPAA ComplianceInternational Standards

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

8–12+ years in medical device regulatory affairs
Direct hands-on U.S. FDA experience across the full device lifecycle
Direct experience with connected hardware and software/SaMD
Experience auditing and building a QMS under 21 CFR 820 and/or ISO 13485
Experience with SOC 2 Type II and HIPAA compliance programs
Track record leading or directly supporting FDA submissions, inspections, and audits
Hands-on experience with device classification, 510(k), De Novo, and PMA submissions, and post-market compliance
Comfortable being the sole regulatory owner at a scaling company
Ability to own QMS, post-market surveillance, adverse event reporting, complaint handling, and compliance programs
Ability to work physically in the United States
RAC (Regulatory Affairs Certification), US Medical Devices track, ASQ CQA or CBA, ISO 13485 Lead Auditor training, AAMI training on 21 CFR 820 / ISO 14971, and international standards experience are nice bonuses, not required
Ability to describe a specific example of escalating compliance failures against business pressure

Benefits

Comp & perks

Equal opportunity employer and commitment to an inclusive environment
Periodic travel to India
Opportunity to collaborate with top healthcare providers and apply AI-powered RPM solutions
Opportunity to work on next-generation healthcare models