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Role Summary:
- The Regulatory Affairs Specialist will secure regulatory approvals for innovative medical devices in India.
- This role works at the intersection of medical technology, compliance, and product innovation.
Key Responsibilities:
- Coordinate domestic and international product filings, registrations, and regulatory submissions.
- Prepare technical documentation and maintain regulatory files for medical device approvals.
- Monitor changes in Indian regulations and communicate updates to global teams.
Requirements:
- Minimum 2 years of experience in Class II or III medical device environments.
- Strong understanding of Indian regulatory submissions and BIS certification.
- Excellent communication and organizational skills.
Benefits:
- Healthcare coverage and paid time off.
- Remote work flexibility and international collaboration.
- Professional development opportunities in regulatory affairs.
Jobgether
The company develops innovative medical devices and operates in a global healthcare technology environment. It values regulatory compliance, cross-functional collaboration, and professional growth, with a remote-friendly and internationally connected culture.