QA/RA & Compliance Executive

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 Good 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