active · Approximate location
Head of Global Regulatory and Quality Affairs
full timeHouston, Texas
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AT A GLANCE
Product & TechnologyFull Time
Company Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company. We are seeking visionary individuals to help us in this ve
About the role
Company Overview : Dozee Health AI is the pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. Headquartered in Bengaluru, India, Dozee has emerged as India’s no. 1 RPM Company. We are seeking visionary individuals to help us in this very exciting journey. As a part of our dynamic team, you’ll have the opportunity to collaborate with top healthcare providers in the country, applying AI-powered RPM solutions to tackle some of the most pressing challenges in healthcare - enhancing staff efficiency, improving patient outcomes, and pioneering the next generation of care models
Dozee is a contactless remote patient monitoring platform — a patented, under-mattress sensor delivering hospital-grade remote patient monitoring so care teams catch deterioration earlier and act sooner. We're hiring a Head of Regulatory and Quality Affairs, to own our quality and regulatory strategy and compliance backbone end to end — from FDA submissions and audits through the quality, security, and privacy standards that let providers and patients trust our hardware and software.
This is a builder-owner role. You're not one voice on a larger RAQA team — you're the person who sets the strategy, runs point with FDA, and builds the systems that keep us compliant as we scale.
Not credentials alone. We are specifically looking for someone who has previously worked in an environment with business pressure to override compliance, and who documented, escalated, and held the line, and who can describe how they sustained that rigor.
Responsibilities
- Serve as the primary point of contact for QMS structuring and implementation and regulatory projects working directly alongside regulatory counsel.
- Conduct or oversee an independent internal assessment of current regulatory and quality structure.
- Own and implement CAPA processes.
- US FDA regulatory strategy: device classification, pathway selection, and 510(k)/De Novo/PMA submissions for connected hardware and companion software (including SaMD).
- Quality Management System: 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, while based in the US to interface directly with FDA.
- SOC 2 Type II and HIPAA compliance as ongoing programs.
- 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 on a defined cadence.
- Lead FDA audits and inspections — be the primary point of contact for FDA inspections, and prepare the team and documentation.
- Advise Product and Engineering — review design changes, new features, and hardware revisions for regulatory impact.
- Partner with global teams on international standards — where relevant, align our documentation and quality systems with standards used by international teams and partners (e.g., ISO, MDR-adjacent practices), even though the core mandate is U.S. FDA compliance.
- Other international markets: Continue ongoing CE compliance and enable other international regulatory clearances based on business goals.
- Report regulatory health to leadership — submission status, audit readiness, and certification timelines, translated into clear updates for the CEO/Founder and other stakeholders.
- Team — nurture and build on the team of regulatory affairs specialists.
Requirements
- This role requires physical presence in the US, with periodic travel to India (most of the R&D/QA team is based there). This is not a remote or hybrid-from-a-distance role. FDA inspections and correspondence can require same-day, on-site response.
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