About this role
Support new product registrations and license renewals for medical device and fertility products in India, Sri Lanka, and Nepal, ensuring compliance with applicable local regulatory requirements. Act as the primary regulatory liaison with external consultants, distributors, and local health authorities, coordinating all regulatory‑related communications, submissions, responses, and follow‑ups. Ensure timely progression of regulatory activities, proactive issue resolution, and alignment between internal stakeholders and external parties to support uninterrupted market access and regulatory compliance.
Knowledge, Skills and Abilities:
- 3 -5 years of experience in Medical Device Regulatory Affairs
- Knowledge on GDPMD would be an advantage
- Knowledge on post market reporting would be an advantage
- Mandatory knowledge for regulatory submission in India
- Additional knowledge of regulatory environment in Sri Lanka and Nepal would be an advantage
Work Environment:
- Office based
Experience:
- 3 – 5 years experience in Medical Device Industry
Education:
- Bachelor’s degree in any Science related field