Regulatory Affairs Specialist
Company: Meril Life Sciences
Location: Andheri (E), Mumbai
Experience: 1 to 6 years
Work Schedule: 6 days (Monday to Saturday), Work from Office
Join Our Team at Meril Life Sciences!
Are you passionate about maintaining the highest standards in medical device approvals and global regulatory compliance? We have an exciting opportunity for you!
Position Overview:
- 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.
How to Apply:
Send your resume to akshay.revankar@merillife.com.
