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 Valuable 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