Key Responsibilities

- Manage and maintain the company’s Quality Management System (QMS).

- Ensure compliance with applicable ISO, MDR/medical device regulations, and regulatory requirements.

- Prepare, review, and maintain SOPs, quality manuals, policies, forms, and other quality documents.

- Handle regulatory submissions, registrations, licenses, renewals, and approvals.

- Coordinate with regulatory authorities, notified bodies, auditors, and external agencies.

- Ensure compliance with applicable medical device regulations and product-specific requirements.

- Manage CAPA, non-conformities, deviations, complaints, and change controls.

- Conduct and coordinate internal audits and external audits.

- Support supplier/vendor qualification and evaluation.

- Review product quality and regulatory documentation before product release.

- Maintain technical documentation, regulatory files, certificates, and compliance records.





- Monitor changes in applicable regulations and ensure timely implementation within the organization.

- Support risk management and post-market surveillance activities, where applicable.

- Investigate customer complaints and coordinate corrective/preventive actions.

- Ensure proper implementation of Positive Documentation Practices (GDP) and quality procedures.

- Provide training to employees on QMS, regulatory requirements, SOPs, and compliance.

- Prepare management reports related to quality performance, compliance, audits, CAPA, and regulatory status.

- Ensure timely closure of audit observations and regulatory compliance gaps.

- Act as the PRRC (Person Responsible for Regulatory Compliance) where applicable and authorized.

Pay: ₹15,000.00 - ₹35,000.00 per month

Work Location: In person

📌 QA/RA & Compliance Executive (Ramol)
🏢 Perfect Medicare Products
📍 Ramol