Posted:3 hours ago|
Platform:
Work from Office
Full Time
- Support in preparing the documentation or dossier as applicable for the product registration and the certifications.
- Update the documents, for response to queries and other requirements as required by respective regulatory authorities in a stipulated time frame.
- Provide assistance in Internal & External audits.
- Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner
- Assist with follow-up audits, as required.
- Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements of
- Identify the related and required documents in line with processes ensuring quality standards.
- On-time release, distribution & obsolete documents as per the company procedure.
- Maintain the QMS documentation, records and file maintenance.
- Coordination with other departments for maintaining the documents.
- Prepare document change order (DCO) and release documents on time and maintain a log.
- Prepare the Engineering change requests, compile, issue and maintain the log.
- Timely preparation and submission of MIS report on a daily/weekly/monthly basis.
Syrma Johari Medtech
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