Regulatory Affairs Executive

• To document, prepared the Quality as well as various technical documents & co-ordinate approval from the Authorize Person as per the Policy of the company and in line with MDR& QMS Requirement..
• To establish the Quality Management System in the company at all levels
• System Management as per ISO 13485 Audits & NCR Closing
• Make Internal Audit function as per the requirement of the Quality Systems
• To co-ordinate within all functions as far as the Quality System is concern
• Make document for Management Review meeting.
• Provide Support Record/Documents to the QA Head about the functioning of the Quality Management Systems in the company during Management Review Meeting.
• To co-ordinate and Prepared the corrective action against internal /External audit findings
• To maintain Quality records pertaining to his function.
• Prepared the required changes in implementing, maintaining and imparting the quality system & get Respective Approval from QA Head.
• Control sample preservation & monitoring
• Review of BMR
• High Light System Related Deviation throughout Company & Report to QA Head.
• Monitoring Objective of each Functions Records & get approval on monthly bases from authority.
• Handling Complaint.
• Issuance of Batch Through BMR/IPQC control Formats
• Weekly verification of various Department.
• Monitoring Schedule of all validation, calibration, stability, control sample, observation, Bio burden, Fumigation.
• Prepared & Monitoring of Process Validation, machine validation etc.
• Improve awareness among team member for effective IPQC.
• Co-ordinate for Design Development, Post market surveillance, Risk management analysis, field safety corrective action etc.
• Being an Active Participant for Continuous Improvement/various Product development activities.
• Raising Change Note /Suggestion.
• Maintaining Stock of Printed Documents.
• Maintain & Monitoring of Monthly QC Report & BMR Status

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

• Leave encashment
• Paid sick time
• Paid time off
• Provident Fund

Work Location: In person