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.

Role Overview: As a Lead Regulatory Affairs Specialist at Dozee, you will drive global regulatory strategy for our medical devices and SaMD products. You will manage regulatory submissions, ensure compliance with FDA, EU MDR, and international standards, and mentor a growing regulatory team. This role offers the chance to shape the regulatory landscape of cutting-edge healthcare technologies, ensuring safety, efficacy, and timely market access worldwide.

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) requestsTraditional and Special 510(k) submissions and 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 OUS 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 suc

📌 Lead - Regulatory Affairs (Bengaluru)
🏢 Dozee
📍 Bengaluru