Lead Regulatory Affairs Specialist

Dozee(15 days ago)

Bangalore, IndiaOnsiteFull TimeSenior$98,867 - $135,222 (estimated)Regulatory Affairs

About this role

A Lead Regulatory Affairs Specialist at Dozee will shape global regulatory strategy for medical device and SaMD products within an AI-powered remote patient monitoring company. The role supports international market access and regulatory alignment while contributing to product safety and effectiveness and leading a regulatory team.

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Required Skills

Regulatory Strategy
Regulatory Submissions
FDA
EU MDR
SaMD
Design Control
Risk Management
CE Marking
Audit Support
Labeling

+3 more

Qualifications

Bachelor's Degree
MBA (Preferred)
ISO 13485 Auditor Certification

About Dozee

dozeehealth.ai

Dozee is an Indian medtech company best known for the country's first contactless vitals monitor and its remote patient monitoring platform. Its solution combines a contactless bed sensor and connected‑bed technology with AI‑based early‑warning algorithms to continuously track vital signs and flag clinical deterioration. Dozee is used in hospitals, clinics and homecare to reduce manual checks, enable timely interventions, and improve patient oversight. Customers choose Dozee for non‑invasive continuous monitoring, automated alerts, and easier scaling of patient surveillance across settings.