Report To: Sr GM

Job Description:

Ensuring the organization meets all applicable regulations and maintaining the documentation as per the ISO13485, USFDA, MDSAP and other regulations. Overall documentation and guidance to the departments to maintain regulatory compliance, Managing Product registration and certification activities.

Total Experience: 12-17 years

Roles & Responsibility:

- Product Registration & Certification: preparing the documentation as applicable for the product registration and the certifications and submitting in a timely manner.

- Provide responses to regulatory agencies regarding product information or issues.

- Update the documents, for response to queries and other requirements as required by Respective regulatory authorities in a stipulated time frame.

- Regulatory Audits - Internal and External Audit: Manage activities such as audits, regulatory agency inspections, or product recalls.

- Draft, Internal audit reports and coordinate with auditors for the closure of audits in a timely manner.

- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

- Develop regulatory strategies and implementation plans for the preparation and submission of new products.

- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.

- QMS - Maintenance: Compile and maintain regulatory documentation databases as per ISO 13485:2016 and other applicable regulatory requirements.

- 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.

- Change Management: Prepare document change order (DCO) and release documents on time and maintain a log.

- New Product Development: Prepare and release the documentation of the new product within the timeline.

- Reporting: Timely preparation and submission of MIS report on a daily/weekly/monthly basis.

Specific Skill:

- Proficiency in English communication.

- Strong initiative skills, working both independently and as part of a team.

- Advanced Microsoft office skills (Word, Excel, PowerPoint and Outlook).

- Problem-solving skills.

- Committed and dedicated to the assigned task.

- Computer proficiency.

- Good knowledge of current Regulatory / GMP requirements (US FDA, EU MDR, MDSAP).

General Skills:

- Self-motivated.

- Enthusiastic.

- Initiator.