Senior Regulatory Affairs Specialist

Dozee - Turtle Shell Technologies; Bengaluru; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Dozee Health AI in Bengaluru seeks an experienced Regulatory Affairs professional to lead global regulatory strategies for SaMD and medical devices. You will own submissions for US FDA, manage EU CE marking activities, and oversee documentation across regulatory domains.

The role requires extensive experience with FDA Class I/II devices, EU MDR, and ISO 13485. You will mentor junior staff and communicate regulatory changes to global teams, ensuring compliant product launches.

Qualifications

• 5+ years of Regulatory Affairs experience in a regulated industry, preferably medical devices and SaMD.
• Bachelor's degree (MBA a plus).
• Strong experience with US FDA Class I and II medical devices.
• Proven end-to-end experience owning regulatory submissions and approvals.
• Hands-on experience with US FDA, EU Notified Bodies, other international agencies, ISO 13485 Auditor Certification, SaMD regulations, and digital health requirements.

Responsibilities

• Evaluate regulatory strategies to bring products to market globally.
• Review and approve regulatory documentation per FDA, EU MDR, and other regs.
• Author and manage FDA submissions including 510(k) and Q-Sub for SaMD.
• Prepare EU Technical Documentation and CE Marking support under EU MDD/MDR.
• Mentor junior team members and stay current with evolving regulations.

Skills

Regulatory affairs

SaMD regulatory

FDA submissions

EU MDR

Quality systems

Education

Bachelor's degree

MBA beneficial

Job description

Job Summary

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 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.

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, and 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 new 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 global medical device regulations, with strong focus on US FDA and EU MDR.

Requirements

• 5+ years of Regulatory Affairs experience in a regulated industry, preferably medical devices and SaMD.
• Bachelor s degree (MBA a plus)
• Strong experience with US FDA Class I and II medical devices.
• Proven end-to-end experience owning regulatory submissions and approvals, including responding to regulatory deficiencies.
• Hands-on experience working with:

• US FDA
• EU Notified Bodies
• Other international regulatory agencies
• ISO 13485 Auditor Certification (external auditor certification)
• Strong understanding of SaMD regulations and digital health requirements
• Familiarity with AI Acts and software-driven regulatory considerations