Mirrai Careers

Head of Global Regulatory and Quality Affairs

Dozee

Houston, Texas Full-time Posted 12d ago
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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. LOCATION REQUIREMENT 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. HOW THE ROLE WORKS: STRATEGIZE, EXECUTE, SUSTAIN 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. WHAT YOU'LL OWN IMMEDIATE  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. ONGOING (PERMANENT FUNCTION) 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. EXPERIENCE WE'RE LOOKING FOR 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. NICE TO HAVE 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 SKILLS THAT SET YOU UP TO WIN 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. About Dozee (www.dozeehealth.ai)   Vision & Mission Save Million lives with Health AI   Dozee is India’s leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world’s first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs.   Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours.    Videos Science Behind Dozee : Ballistocardiography & Artificial Intelligence 100 Dozee deliver 144 life saving alerts and INR 2.7 Cr of saving - Sattva Study Dozee saves life of a mother at home Leading Healthcare Game changers work with Dozee Introducing Dozee VS Dozee Shravan - A clinical grade RPM service   Dozee in News:   Bloomberg - Oct 21, 2024 From AI Beds to Remote ICUs, Startups are plugging India's health Gaps News18 - Oct 26, 2024 Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan' Analytics India Magazine - Oct 29, 2024 Dozee Harness AI for Personalised Patient Care ET HealthWorld - Sep 16, 2024 We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare? BW healthcareworld - Oct 29, 2024 Dozee's AI-Powered System Predicts Patient Deterioration 16 Hours in Advance   - A tertiary care hospital study published in JMIR, validated Dozee’s Early Warning System (EWS), showing it identified 97% of deteriorating patients, provided alerts ~19 hours in advance, and generated 5x fewer alerts, reducing alarm fatigue and improving patient outcomes. - A study at King George Medical University, Lucknow, and published in Frontiers in Medical Technology demonstrated that Dozee’s automation can potentially save 2.5 hours of nursing time per shift, improving workflow efficiency and allowing more focus on patient care. - A study on remote patient monitoring in general wards published in Cureus found that 90%+ of healthcare providers reported improved care and patient safety, 74% of patients felt safer, and there was a 43% increase in time for direct patient care. - Research by Sattva, an independent consulting firm, demonstrates Dozee's substantial impact: for every 100 Dozee-connected beds, it can save approximately 144 lives, reduce nurses’ time for vital checks by 80%, and decrease ICU average length of stay by 1.3 days.    Key Highlights Founded : October, 2015 Founders :  Mudit Dandwate, Gaurav Parchani Headquarters : Bangalore, India | Houston, USA | Dubai, UAE Key Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnology, State Bank of India, and Dinesh Mody Ventures, Temasek Foundation, Horizons Ventures Stage : Series A+ Team Strength : 280+ Business : Providing Continuum of care with AI-powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) for Hospitals and Home Certifications & Accreditations : ISO13485:2016 Certified, ISO27001:2022 Certified, CDSCO Registered, FDA510K Cleared for the flagship product Dozee Vitals Signs (VS) measurement system and SOC2 Type II Certified Achievements - Forbes India 30 under 30 - Forbes Asia 100 to Watch - Times Network - India Health Awards 2024 for AI innovation in Bharat Healthcare tech - BML Munjal Award for Business Excellence using Learning and Development - FICCI Digital Innovation in Healthcare Award - Anjani Mashelkar Inclusive Innovation Award Marico Innovation For India Award   To know more about life@dozee, click here.     Disclaimer: Dozee is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.” Dozee does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Dozee will not tolerate discrimination or harassment based on any of these characteristics

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