Head of Global Regulatory and Quality Affairs

Dozee•Houston, TX

8d•Onsite

About The Position

Dozee Health AI is seeking a Head of Regulatory and Quality Affairs to own the company's quality and regulatory strategy and compliance backbone. This is a builder-owner role responsible for FDA submissions, audits, and ensuring quality, security, and privacy standards for hardware and software. The ideal candidate has experience navigating business pressure to override compliance, documenting, escalating, and holding the line. This role requires physical presence in the US, with periodic travel to India, and the ability to respond to FDA inspections and correspondence on-site.

Requirements

8-12+ years in medical device regulatory affairs.
Direct hands-on US 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, ideally from early stage.
Experience with SOC 2 Type II and HIPAA compliance programs.
A track record leading or directly supporting FDA submissions, inspections and audits.
Comfortable being the sole regulatory owner at a scaling company — hands-on with submissions and documentation.
FDA fluency: knowledge of submission pathways, inspection process, and post-market obligations.
Builder mindset: experience building QMS and regulatory processes from scratch.
Compliance rigor: ability to hold the line on documentation and quality standards.
Security and privacy fluency: comfortable owning SOC 2 and HIPAA.
Cross-functional comfort: ability to work naturally with Product, Engineering, Quality, and Clinical.
Global standards awareness: ability to translate international requirements into practical guidance.
High ownership at founder speed: ability to move fast, make calls with incomplete information, and take responsibility for outcomes.
Ethical Advocacy: a track record of escalating compliance failures against business pressure, with a specific example.

Nice To Haves

RAC (Regulatory Affairs Certification), US Medical Devices track (RAPS)
ASQ CQA or CBA
ISO 13485 Lead Auditor training (Exemplar Global, BSI, TUV, or equivalent)
AAMI training on 21 CFR 820 / ISO 14971
Experience with international standards (ISO, MDR-adjacent) supporting offshore engineering teams

Responsibilities

Set the regulatory roadmap and define the U.S. regulatory pathway for new hardware and software features.
Own the strategy that keeps releases on schedule.
Lead submissions, respond to FDA correspondence, and own inspections and audits from start to finish.
Own the quality management system, post-market surveillance, and security and privacy certifications.
Serve as the primary point of contact for QMS structuring and implementation and regulatory projects.
Conduct or oversee an independent internal assessment of current regulatory and quality structure.
Own and implement CAPA processes.
Develop and execute US FDA regulatory strategy: device classification, pathway selection, and 510(k)/De Novo/PMA submissions for connected hardware and companion software (including SaMD).
Instrument QMS under 21 CFR 820 and ISO 13485, including design controls, document control, and CAPA.
Build the playbook and advise cross-functional teams on QMS.
Direct and audit compliance work performed by distributed engineering and QA teams, including offshore teams.
Manage SOC 2 Type II and HIPAA compliance as ongoing programs.
Oversee post-market compliance: surveillance, adverse event reporting, and complaint handling.
Report regulatory and quality health directly to the CEO and to an independent board member.
Lead FDA audits and inspections, preparing the team and documentation.
Advise Product and Engineering on regulatory impact of design changes, new features, and hardware revisions.
Partner with global teams on international standards, aligning documentation and quality systems with international standards.
Continue ongoing CE compliance and enable other international regulatory clearances.
Report regulatory health to leadership, including submission status, audit readiness, and certification timelines.
Nurture and build on the team of regulatory affairs specialists.