Dozee·9 days ago
9 days ago
Senior Regulatory Affairs Specialist
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What you'll do
- Collaborate with top healthcare providers in the country
- Apply AI-powered RPM solutions to tackle pressing challenges in healthcare
- Enhance staff efficiency
- Improve patient outcomes
- Pioneer the next generation of care models
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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
○ Regulatory filings for Software as a Medical Device (SaMD)
○ Traditional and Special 510(k) submissions
○ 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.
○ 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.
Company
Dozee
Bengaluru, India
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