Job Title: Regulatory Affairs Specialist Location: CNC Path Labs Employment Type: Full-Time / Contract Basis About the Role CNC Path Labs is seeking a highly organized and detail-oriented Regulatory Affairs Specialist to independently manage all regulatory, compliance, and quality assurance activities. The ideal candidate will take full ownership of ISO documentation, CDSCO regulatory processes, and overall QA tasks to ensure the company meets all national and international compliance standards. Key Responsibilities Regulatory Compliance (ISO & CDSCO) Lead and maintain end-to-end compliance for ISO 15189 , ISO 13485 , and other relevant standards. Prepare, update, and manage all required documentation, manuals, SOPs, protocols, and logs. Coordinate all internal and external ISO audits and ensure timely closure of NCs/CAPAs. Oversee CDSCO regulatory submissions , including Form approvals, device registrations, permissions, and license renewals. Maintain a compliance calendar to ensure no deadlines or renewals are missed. Documentation & Quality Assurance Develop, revise, and implement Quality Management System (QMS) documentation. Prepare technical files, dossiers, risk assessments, and validation records. Ensure all laboratory practices align with national guidelines and IVD regulatory norms. Monitor and maintain QC logs, equipment calibration records, and proficiency testing documentation. Carry out routine internal audits, gap analyses, and regulatory risk assessments. Implement CAPA processes, track corrective actions, and ensure document traceability. Regulatory Coordination Act as the primary point of contact for regulatory bodies, auditors, and certification agencies. Support new product filings, labeling compliance, and regulatory updates as required. Track new regulatory requirements and update internal policies accordingly. Process Improvement Identify areas of improvement within the QMS and implement best practices. Ensure continuous readiness for audits and inspections. Qualifications & Requirements Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biochemistry, Microbiology, or related field. 2–5 years of regulatory affairs or quality assurance experience (preferably in diagnostics, pathology labs, or IVD industry). Strong knowledge of ISO 15189, ISO 13485, NABL guidelines, and CDSCO regulatory processes. Excellent documentation skills and strong attention to detail. Ability to manage regulatory tasks independently without supervision. Strong communication and coordination skills. What We Offer Competitive salary and performance incentives. Opportunity to lead regulatory affairs for a fast-growing diagnostics and biotech company. Autonomous role with full ownership of compliance and QA functions.
Company Description CNC Path Lab is an advanced clinical laboratory based in Delhi, India, focused on revolutionizing diagnostic services through cutting-edge technologies and innovative solutions. Established by Mr. Aditya Saini, the lab offers a wide range of routine and specialized tests with a strong emphasis on quality patient care. Equipped with state-of-the-art automation, CNC Path Lab also provides 24/7 customer support and a convenient sample home collection service. Accredited by NABL and ICMR, the lab is supported by a team of specialized doctors offering teleconsultation services in various fields, making it a comprehensive healthcare partner. Committed to delivering reliable and timely diagnostic information, CNC Path Lab strives to make a positive impact on the community. Role Description This is a full-time on-site role for a Medical Laboratory Technician located in Delhi, India. The Medical Laboratory Technician will be responsible for performing diagnostic tests, managing and maintaining laboratory equipment, ensuring quality control, and supporting laboratory functions to deliver accurate and timely results. Daily tasks will include preparing specimens for analysis, operating laboratory instruments, and collaborating with healthcare professionals to assist with patient care. Qualifications Proficiency in Medical Technology and Laboratory Medicine Strong Laboratory Skills, including preparation and handling of samples Experience with Laboratory Equipment and its maintenance Knowledge of Quality Control procedures and ensuring compliance with standards Attention to detail and accuracy in diagnostic procedures Good communication and problem-solving skills Bachelor’s degree or diploma in medical laboratory technology or a related field Previous experience in a NABL-accredited laboratory is an advantage