Location: Bangalore, India
Department: Quality Assurance & Regulatory Affairs
Job Type: Full-Time
Work Mode: On-Site
Experience Required: 6+ Years
About Dozee Health AI
Dozee Health AI is a global digital health company pioneering AI-powered, contactless Remote Patient Monitoring (RPM) and Early Warning Systems (EWS). Headquartered in Bengaluru, Dozee enables continuous patient monitoring across hospitals, long-term care facilities, and home healthcare environments.
Recognized as India’s leading RPM provider, Dozee supports 300+ hospitals and monitors over 16,000 beds across multiple countries. Its clinically validated AI platform improves early detection of patient deterioration, enhances workflow efficiency, and reduces alarm fatigue.
As part of its global regulatory expansion, Dozee is seeking an experienced Lead Regulatory Affairs Specialist to drive international regulatory strategy for medical devices and Software as a Medical Device (SaMD) solutions.
Role Overview
The Lead Regulatory Affairs Specialist will define and execute global regulatory strategies to ensure timely product approvals and market access across the United States, European Union, and other international markets.
This role is critical in navigating complex regulatory landscapes including US FDA regulations, EU MDR requirements, AI-driven compliance frameworks, and emerging global standards for digital health and SaMD products. The position also involves mentoring regulatory professionals and supporting cross-functional product development initiatives.
Key Responsibilities
Global Regulatory Strategy & Submissions
Develop and execute regulatory strategies for medical devices and SaMD products across global markets.
Author and manage US FDA submissions, including:
Q-Submissions (Q-Sub)
Traditional and Special 510(k) applications
Regulatory filings for Software as a Medical Device (SaMD)
Prepare and maintain EU Technical Documentation and support CE Marking under EU MDD/MDR frameworks.
Independently assess product modifications for regulatory impact and prepare required notifications for US, EU, and other international markets.
Regulatory Compliance & Documentation
Review and approve design control documentation, risk management files, and labeling in compliance with FDA, EU MDR, and international standards.
Maintain regulatory databases, submission trackers, and documentation systems.
Support regulatory inspections, audits, CAPAs, and compliance initiatives.
Review advertising and promotional materials for regulatory alignment.
Emerging Regulations & AI Governance
Monitor evolving global regulations, including digital health standards and AI governance frameworks such as the EU AI Act.
Communicate regulatory updates and impact assessments to cross-functional teams.
Ensure regulatory alignment for AI-enabled medical technologies.
Leadership & Cross-Functional Collaboration
Lead regulatory training initiatives across teams.
Mentor and develop junior regulatory professionals.
Collaborate with R&D, Quality, Clinical, and Product teams to ensure regulatory readiness throughout the product lifecycle.
Required Qualifications
Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related discipline (MBA preferred).
Minimum 6+ years of Regulatory Affairs experience in a regulated industry, preferably medical devices and SaMD.
Strong experience with US FDA Class I and II medical devices.
Proven end-to-end ownership of regulatory submissions and approvals, including response to regulatory deficiencies.
Hands-on experience working with:
US FDA
EU Notified Bodies
Other international regulatory agencies
ISO 13485 Auditor Certification (external auditor certification preferred).
Deep understanding of global medical device regulations with strong expertise in US FDA and EU MDR.
Experience with digital health, AI-driven software products, and SaMD regulatory pathways.
Preferred Competencies
Familiarity with AI regulatory frameworks and emerging global compliance standards.
Strong analytical and risk assessment capabilities.
Excellent documentation, communication, and stakeholder management skills.
Ability to operate in a fast-paced, innovation-driven healthcare technology environment.
Why Join Dozee
Lead regulatory strategy for AI-powered healthcare technologies with global impact.
Contribute to products validated in peer-reviewed clinical studies.
Work in a high-growth, Series A+ digital health company with international expansion.
Collaborate with cross-border teams across India, the United States, and other global markets.
Dozee’s Early Warning System has demonstrated high sensitivity in identifying deteriorating patients while significantly reducing alarm fatigue and improving clinical efficiency. The organization continues to expand its regulatory footprint globally, supported by robust quality certifications and international compliance standards.
Equal Opportunity & AI Hiring Disclosure
Dozee is an equal opportunity employer committed to diversity, inclusion, and merit-based hiring. Employment decisions are based on qualifications, experience, and business needs.
Artificial intelligence tools may support parts of the recruitment process, including resume screening and application analysis. These tools assist hiring teams but do not replace human judgment. Final hiring decisions are made by authorized personnel.
Apply via ThePharmaDaily.com
Regulatory professionals seeking to lead global compliance strategy for AI-enabled medical devices and SaMD solutions are encouraged to apply and contribute to the next generation of healthcare innovation.
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