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 prospect 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
- Plan, establish, implement, maintain, and continuously improve the Quality Management System (QMS) in accordance with EN ISO 13485 and applicable medical device regulatory requirements.
- Drive QMS streamlining and process improvements across functions to ensure effective, efficient, and compliant quality processes throughout the product lifecycle.
- Develop, review, and maintain quality policies, procedures, SOPs, work instructions, forms,



and quality records in alignment with regulatory and organizational requirements.
- Ensure effective implementation and maintenance of Design Controls, Document Control, Change Control, Risk Management, CAPA, Non-Conformance, Complaint Handling, Supplier Quality, Training, and other QMS processes.
- Support regulatory compliance with applicable standards and regulations, including US FDA, EU MDR/CE Marking, CDSCO, IEC 60601, IEC 62304, ISO 14971, and other relevant requirements.
- Prepare and maintain regulatory dossiers, Device Master Files/Technical Documentation, and quality-related documentation required for regulatory submissions and product lifecycle activities.
- Work closely with Product Development, Product Transfer, Manufacturing, Engineering, and other cross-functional teams to ensure QMS and regulatory requirements are effectively implemented.
- Provide guidance to cross-functional teams on qual

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Dozee
📍 Bengaluru