Quality Assurance & Regulatory Affairs

Quality Assurance & Regulatory Affairs Executive Role Overview The Quality Analysis & Regulatory Affairs professional will be responsible for establishing, maintaining, and improving quality systems while managing regulatory submissions and compliance for IVD products. This role requires a hands-on approach, cross-functional collaboration, and the ability to work in a dynamic startup environment. Key Responsibilities Quality Analysis / Quality Assurance • Establish, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements. • Prepare, review, and control quality documentation including SOPs, work instructions, records, and forms. • Conduct internal audits, gap assessments, and support external audits (certification bodies, regulators, customers). • Manage CAPA, deviations, change controls, and non-conformances. • Support risk management activities (ISO 14971) including risk analysis and mitigation. • Oversee incoming, in-process, and final quality checks for IVD products. • Ensure product traceability, batch release documentation, and quality records maintenance. Regulatory Affairs • Manage regulatory submissions and approvals for IVD products (India CDSCO and/or international markets). • Prepare and maintain technical documentation / dossiers, including device master files, labeling, IFUs, and validation reports. • Ensure compliance with applicable regulations such as IVDR / ICMR / CDSCO / CE / FDA (as applicable). • Act as the primary point of contact for regulatory authorities and notified bodies. • Monitor regulatory updates and assess impact on existing and upcoming products. • Support product registration, renewals, variations, and post-market compliance activities. Cross-Functional Collaboration • Work closely with R&D, Manufacturing, Supply Chain, and Operations teams to ensure quality and regulatory requirements are met throughout the product lifecycle. • Provide regulatory and quality guidance during product development, scale-up, and commercialization. Qualifications & Experience • Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biomedical Engineering, Pharmacy, or related field. • 2–6 years of experience in Quality Assurance and/or Regulatory Affairs within IVD or medical device industry. • Strong knowledge of ISO 13485, ISO 14971, and IVD regulatory frameworks. • Experience with CDSCO / CE / FDA submissions is a strong advantage. • Familiarity with validation, documentation control, and audit processes. Job Type: Full-time Pay: ₹30,000.00 - ₹45,000.00 per month Work Location: In person