Senior Regulatory Affairs Specialist

About this role

Not quite right? These jobs in Bengaluru match the same skills — apply to a few to improve your chances.

Senior Regulatory Specialist

Stryker

In OfficeBengaluru

Apply

Regulatory Affairs Specialist

ZEISS

In OfficeBengaluru

Apply

Regulatory Affairs Specialist

Dozee

In OfficeBengaluru

Apply

Senior Regulatory Affairs Associate

Parexel

RemoteBengaluru

Apply

What you'll do

• 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)
• 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.

Who can apply

• 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.
• Vision & Mission
• Save Million lives with Health AI
• Dozee is India’s leading AI-Powered contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS). A solution that continuously monitors patients and provides early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities and patient homes. A "Made in India for the World" solution, Dozee has pioneered the world’s first non-contact blood pressure monitoring system. Trusted by leading healthcare providers in India, the USA, and Africa, Dozee is transforming patient safety and care by enhancing outcomes and reducing costs.
• Dozee is adopted by 300+ hospitals and monitors 16000+ beds across 4 countries. Dozee has monitored over 1 Mn Patients, Delivered 35000+ Life Saving Alerts and Saved 10 Mn+ Nursing Hours.

About Dozee

Searching for “Dozee jobs” or “jobs at Dozee”? You’re in the right place.