Regulatory Affairs Specialist @ Meril Life Sciences
About Company
Located in Vapi, Gujarat, India, Meril Life Sciences is a worldwide medical device firm. It is a member of the Bilakhia Group and was established in 2006.
Position Name: Regulatory Affairs Specialist
Organization: Meril Life Sciences
Position Overview:
Join our team at Meril Life Sciences as a Regulatory Affairs Specialist. You will be responsible for ensuring the highest standards in medical device approvals and global regulatory compliance.
Key Responsibilities:
| Task | Description |
|---|---|
| Manage Global Submissions | Handle dossier submissions for medical devices globally. |
| Coordinate Approvals | Work with Ministries of Health to secure device approvals and address related queries. |
| Collaborate Internally | Work closely with R&D and Plant QA/RA teams for dossier compilation. |
| Global Communication | Engage with distributors and consultants worldwide to secure approvals. |
| Support International Registration | Assist the Sales Team with country-specific registrations. |
| Maintain Records | Keep submission records up-to-date and precise. |
| QMS Documentation | Prepare and monitor Quality Management System documentation for audits based on country-specific requirements. |
Key Qualifications:
- Detail-oriented with excellent communication skills.
- Ability to thrive in a dynamic, international environment.
Job Details:
| Location | Andheri (E), Mumbai |
|---|---|
| Experience | 1 to 6 years |
| Work Schedule | 6 days (Monday to Saturday), Work from Office |
How to Apply:
Send your resume to akshay.revankar@merillife.com.
