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 chance 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 recent 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