Lead Regulatory Affairs Specialist

Dozee Health AI is a pioneer in Contactless Remote Patient Monitoring (RPM), proven to drive transformation at scale. We are seeking a Lead Regulatory Affairs Specialist to drive global regulatory strategy for our medical devices and SaMD products.

Requirements

• 6+ 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, and 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.

Benefits

• Competitive salary
• Benefits package
• Opportunity to work with a pioneer in Contactless Remote Patient Monitoring (RPM)
• Chance to shape the regulatory landscape of innovative healthcare technologies