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 energetic 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 innovative healthcare technologies, ensuring safety, efficacy, and timely market access worldwide.

Responsibilities
- Plan,



establish and maintain a Quality Management System in accordance with EN ISO 13485
- Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA and CE Marking, etc
- Prepares dossiers and device master files for regulatory submissions
- Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed and provide directions for compliance to the organization.
- Work with different teams to setup Quality policies and standards
- Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards.
- Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations.
- Working closely with product development and product transfer teams Supplier Audit and Qualificati

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Dozee
📍 Bengaluru