Regulatory Affairs Specialist
2 weeks ago
The Regulatory Affairs Specialist will play a key role in ensuring compliance with regulatory requirements for medical devices in India, Sri Lanka, and other SWA countries. This includes preparing and submitting regulatory submissions, interacting with regulatory agencies and health authorities, and ensuring timely product approvals.
Key Responsibilities:
- Prepare and submit product import license applications, renewals, and post-approval change applications.
- Coordinate with the Business Units Regulatory Affairs team to request documents for applications.
- Respond to queries raised by regulatory authorities against submitted applications.
- Ensure timely project completion and meet compliance requirements.
- Provide proactive regulatory intelligence and stay up-to-date with agency regulations and requirements.
Requirements:
- 8-10 years of experience in the medical devices or IVD industry with a degree in a science-related field.
- In-depth knowledge of Indian and other jurisdiction regulatory requirements.
- Experience in working in a matrix organization and managing people.
- Excellent analytical and problem-solving skills, as well as interpersonal skills with diplomacy, negotiation, and teamwork.
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