CNC Pathlab

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.