QA And RA Speacilist Contractual Role

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 new 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
• Good understanding of QMS documentation, regulatory dossiers, technical files, product registration, and audit compliance.
• Strong documentation, coordination, analytical, and communication skills.