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 agile 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

📌 Senior Regulatory Affairs Specialist (Bengaluru)
🏢 Dozee
📍 Bengaluru