Assistant Manger (Regulatory Affairs)

Job Summary

Urgent Opening @ Manufacturing Unit.

Designation

Assistant Manager (Regulatory Affairs)

Qualifications

Graduate or Post Graduate

Department

Regulatory Affairs Dept.

Experience

03 to 07 Years

Location

Vadodara

Job Profile

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.

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