Head of Global Regulatory and Quality Affairs

Dozee•Dallas/Fort Worth, TX

8d•Onsite

About The Position

Dozee Health AI is seeking a Head of Regulatory and Quality Affairs to lead their quality and regulatory strategy and compliance. This is a builder-owner role responsible for FDA submissions, audits, and ensuring quality, security, and privacy standards for their hardware and software. The ideal candidate has experience navigating business pressure against compliance and can demonstrate how they maintained rigor in such situations. The role requires physical presence in the US with periodic travel to India and involves strategizing regulatory roadmaps, executing FDA submissions and inspections, and sustaining compliance through quality management systems, post-market surveillance, and security certifications.

Requirements

8-12+ years in medical device regulatory affairs with 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, not just strategy.
FDA fluency: understanding of submission pathways, inspection process, and post-market obligations.
Builder mindset: experience building QMS and regulatory processes from scratch.
Compliance rigor: ability to maintain documentation and quality standards under pressure.
Security and privacy fluency: comfortable owning SOC 2 and HIPAA as living programs.
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 decisions 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

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, including device classification, pathway selection, and submissions (510(k)/De Novo/PMA) for connected hardware and companion software (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.
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, including surveillance, adverse event reporting, and complaint handling.
Report regulatory and quality health directly to the CEO and an independent board member.
Lead FDA audits and inspections, acting as the primary point of contact and 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 and align documentation and quality systems with international standards (e.g., ISO, MDR-adjacent practices).
Continue ongoing CE compliance and enable other international regulatory clearances based on business goals.
Report regulatory health to leadership, including submission status, audit readiness, and certification timelines.
Nurture and build the team of regulatory affairs specialists.