Urgent Opening @ Manufacturing Unit.
Designation: Assistant Manager (Regulatory Affairs)
Qualification: Graduate or Post Graduate
Dept.: Regulatory Affairs Dept.
Experience: 03 to 07 Years
Package: As per Experience & Qualification
Job Location: Waghodia GIDC, Vadodara,
Facility: Transportation Available from Vadodara
- ⬥ Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
- ⬥ Timely compile materials for license renewals, updates and registrations
- ⬥ Maintain regulatory files/databases and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
- ⬥ Review labeling and labels for compliance with regulatory requirements
- ⬥ Review changes to existing products and SOPs to define the requirements for regulatory submissions
- ⬥ Provide the regulatory reviews of customer complaints and define the regulatory report ability.
- ⬥ Documents preparation for ISO13485, CE Certificate (As per EU MDR).
- ⬥ Work on a technical master file.
- ⬥ Work on CERs (clinical evaluation report) as per EU MDR.
- ⬥ Have knowledge about QMS (quality management systems).
- ⬥ Reporting to regulatory authorities.
- ⬥ Conducting internal quality audits.
- ⬥ Responsibilities for initiating & closing product recall Process.
- ⬥ Have experience or knowledge of European CE (MDD & MDR).
- ⬥ Have knowledge of USFDA
- ⬥ Other activities instructed by Manager.
Send me your resume on hr@sharmaortho.com
What’s up on +91 70486 92452 / 072288 31595