Regulatory Affairs Officer
United Hr Solutions Private Limited
Regulatory Affairs Officer
United Hr Solutions Private Limited
Ahmedabad
₹25,000 - ₹40,000 monthly
Fixed
₹25000 - ₹40000
Earning Potential
₹40,000
Work from Office
Full Time
Min. 3 years
Good (Intermediate / Advanced) English
Job Details
Interview Details
Job highlights
4 applicants
Job Description
Greetings from United HR Solutions!
Role Summary
Responsible for regulatory and quality activities for Class I & II medical devices, ensuring compliance with EU MDR, CE, and ISO 13485 requirements.
Key Responsibilities
- Manage and maintain regulatory data (EUDAMED, MoH portals, internal systems).
- Review regulatory and technical documentation for CE/MDR compliance.
- Verify CE, ISO, and related certificates.
- Perform supplier/manufacturer qualification and desktop evaluations.
- Support QMS activities, SOP development, and document approvals.
- Coordinate with manufacturers and internal teams on product-related issues
Job role
Work location
Ahmedabad, Gujarat, India
Department
Quality Assurance
Role / Category
Quality Assurance - Other
Employment type
Full Time
Shift
Day Shift
Job requirements
Experience
Min. 3 years
Education
Graduate
Skills
Medical Equipments, Drugs and Medicine, Pharmaceutical products, Medical devices, Regulatory affairs
English level
Good (Intermediate / Advanced) English
Degree/ Specialisation
Any M.Pharm, Any B.Pharm (Atleast one)
Age limit
18 - 30 years
Gender
Any gender
About company
Name
United Hr Solutions Private Limited
Address
Ahmedabad, Gujarat, India
Job posted by United Hr Solutions Private Limited
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