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.

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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

📌 Regulatory Affairs Specialist (Bengaluru)
🏢 Dozee
📍 Bengaluru