Regulatory Affairs Executive

2 weeks ago

Sari Ahmedabad Gujarat, India Medicare Hygiene Ltd Full time

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

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