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Houston, Texas, United States
Onsite
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.
Strategize — set the regulatory roadmap. Define the U.S. regulatory pathway for new hardware and software features, and own the strategy that keeps releases on schedule.
Execute — run point with FDA. Lead submissions, respond to FDA correspondence, and own inspections and audits from start to finish.
Sustain — keep the system compliant at scale. Own the quality management system, post-market surveillance, and the security and privacy certifications our customers require.
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.
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, not just single-product or paper-based devices.
Experience auditing and building a QMS under 21 CFR 820 and/or ISO 13485, ideally from early stage.
SOC 2 Type II and HIPAA compliance programs, either owning them directly or working closely with the teams that do.
Exposure to global regulatory teams or international standards is a strong plus, though the core requirement is deep U.S. FDA fluency.
A track record leading or directly supporting FDA submissions, inspections and audits, with outcomes you can speak to.
8–12+ years in regulatory affairs for medical devices, with hands-on U.S. FDA experience across the full device lifecycle — classification, submissions (510(k)/De Novo/PMA), and post-market.
Comfortable being the sole regulatory owner at a scaling company — hands-on with submissions and documentation, not just strategy.
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
FDA fluency. You know the submission pathways, inspection process, and post-market obligations well enough to run them without hand-holding.
Builder mindset. You've built QMS and regulatory processes from scratch, not just maintained an existing one.
Compliance rigor. You hold the line on documentation and quality standards even as the team moves fast.
Security and privacy fluency. You're comfortable owning SOC 2 and HIPAA as living programs, not checkbox exercises.
Cross-functional comfort. You work naturally with Product, Engineering, Quality, and Clinical to implement regulatory rigor at the design stage.
Global standards awareness. You can translate international requirements into practical guidance for a US-first organization.
High ownership at founder speed. You 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 you can walk through: what you flagged, what happened when you were overruled, and what you did next.
