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Quality & Regulatory
Regulatory Affairs Specialist
Dehradun, India 3-7 years On-site
Job IDSFX-JOB-H6OUAX
About the Role
You will manage regulatory submissions and quality documentation, ensuring our devices meet CDSCO and international standards as we expand globally.
What you'll do
- Prepare and maintain regulatory submissions
- Own technical files and quality documentation
- Track evolving standards across target markets
- Support audits and post-market surveillance
What we're looking for
- Experience in medical-device regulatory affairs
- Knowledge of ISO 13485 and CDSCO processes
- Excellent attention to detail
Nice to have
- Exposure to EU MDR or US FDA pathways
- Cardiology/diagnostics domain knowledge
Why Sunfox
You'll help build clinical-grade cardiac technology that reaches the next billion — from a lab in the lap of the Himalayas. We offer competitive pay, real ownership, and work that saves lives.
Ready to join?
Build tech that saves lives.
Submit your application and our team will get back to you within a few days.
Quick 5-minute applicationDirect response from our teamNo login required