Regulatory Affairs

2 days ago

Jodhpur, Rajasthan, India Syrma Johari Medtech Full time ₹ 1,20,000 - ₹ 1,80,000 per year

Role & responsibilities

1. Product Registration & Certification

  • 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.

2. Regulatory Audits -Internal and External Audit

  • 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.

3. QMS-Maintenance

  • 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.

4. Change Management

  • 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.

5. Reporting

  • Timely preparation and submission of MIS report on a daily/weekly/monthly basis.

Preferred candidate profile

  1. Proficiency in English communication.
  2. Strong initiative skills, working both independently and as part of a team.
  3. Advanced Microsoft office skills (Word, Excel, PowerPoint and Outlook).
  4. Problem-solving skills.
  5. Committed and dedicated to the assigned task.

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