Job Summary

We are looking for a Quality & Regulatory Affairs professional with 34 years of experience in Quality Management Systems (QMS), regulatory compliance, medical device regulations, and audit management. The role will be responsible for maintaining the QMS, ensuring regulatory compliance, managing audits, supporting regulatory submissions, and maintaining product registration and UDI requirements.

Key Responsibilities
Develop, implement, maintain, and continuously improve the Quality Management System (QMS).
Ensure compliance with ISO 13485, ISO 9001, FDA, CE/MDR, and other applicable regulatory requirements.
Plan and coordinate internal, external, customer, certification, and regulatory audits.
Ensure products comply with applicable regulatory and quality requirements across relevant markets.
Prepare, review, and maintain technical files, regulatory dossiers, product documentation, and registration records.
Coordinate regulatory submissions for product approvals, certifications, registrations, and renewals.
Liaise with regulatory authorities, notified bodies, certification agencies, and other external stakeholders.
Monitor changes in international standards and country-specific regulations and assess their impact on products and processes.




Support market access activities for recent products, product modifications, and regulatory changes.
Maintain and update UDI (Unique Device Identification) records, UDI barcodes, registration certificates, and related regulatory documentation.
Support CAPA, non-conformity, change control, risk management, and continuous improvement activities as applicable.
Ensure quality and regulatory documentation is accurate, current, controlled, and readily available for audits.

Required Experience & Knowledge
3–4 years of relevant experience in Quality Management Systems and Regulatory Compliance.
Experience in medical devices, ophthalmic products, or manufacturing is preferred.
Hands-on experience in regulatory submissions and external/customer/certification audits.
Working knowledge of
ISO 13485
ISO 9001
ISO 14971
FDA 21 CFR Part 820
Medical Device Regulation (MDR)
CDSCO requirements
CE requirements
UDI requirements
Valuable understanding of QMS documentation, regulatory dossiers, technical files, product registration, and audit compliance.
Solid documentation, coordination, analytical, and communication skills.

📌 Qa And Ra Speacilist Contractual Role Gurugram
🏢 VISION RX LAB
📍 Gurugram