Senior Regulatory Affairs Specialist

Job description

Overview: Dozee Health AI is a 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. Responsibilities : • Evaluate medical device and SaMD regulations and develop global regulatory strategies to bring products to market. • Review and approve design control documentation, risk management files, and product labeling in accordance with FDA, EU MDR, and other international regulations Author and manage FDA submissions, including: • Q-Submission (Q-Sub) requests • Traditional and Special 510(k) submissions • Regulatory filings for Software as a Medical Device (SaMD) • Prepare and maintain EU Technical Documentation and support CE Marking activities under EU MDD/MDR. • Independently assess product changes for regulatory impact (US FDA, CE Mark, and US markets) and prepare resulting regulatory notifications • Communicate regulatory changes to global regions and support preparation of global submissions and notifications. • Stay current with new and evolving regulations, including emerging requirements such as the EU AI Act, and communicate impacts to project teams. • Maintain regulatory databases, systems, and submission trackers • Support regulatory inspections, audits, CAPAs, and other compliance-related activities. • Review advertising and promotional materials for regulatory compliance. • Participate in and lead regulatory training initiatives • Mentor and support the development of junior regulatory team members. • Comprehensive understanding of global medical device regulations, with strong focus on US FDA and EU MDR. Requirements: • 5+ years of Regulatory Affairs experience in a regulated industry, preferably medical devices and SaMD. • Bachelor’s degree (MBA a plus) • Strong experience with US FDA Class I and II medical devices. • Proven end-to-end experience owning regulatory submissions and approvals, including responding to regulatory deficiencies. • Hands-on experience working with: • US FDA • EU Notified Bodies • Other international regulatory agencies • ISO 13485 Auditor Certification (external auditor certification). • Strong understanding of SaMD regulations and digital health requirements. • Familiarity with AI Acts and software-driven regulatory considerations. 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 DozeeI • 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 News18Oct 26, 2024 Now, You Can Remotely Monitor Your Loved Ones in Hospital With Bengaluru Start-Up's 'Shravan' Analytics India MagazineOct 29, 2024 Dozee Harness AI for Personalised Patient Care ET HealthWorldSep 16, 2024 We trust AI everyday - From Google Maps to Smartphones, So why not use it to enhance patient safety in healthcare? BW healthcareworldOct 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 \\u007C Houston, USA \\u007C Dubai, UAE • Key Investors & Backers : Prime Ventures, 3one4 Capital, YourNest Capital, Gokul Rajaram, BIRAC (Department of Biotechnolo