Company Description Edusoft Healthcare Limited is at the forefront of healthcare innovation, specializing in delivering top-notch radiology equipment for enhanced diagnostics and improved patient outcomes. We are committed to redefining radiology excellence by providing advanced technology solutions. Based in New Delhi, Edusoft Healthcare is dedicated to continuous improvement and driving better healthcare experiences. Role Description This is a full-time, on-site role for an RSO & QA Manager, located in New Delhi. The RSO & QA Manager will be responsible for overseeing the radiation safety operations and ensuring quality assurance in radiology services. Type approval, day-to-day tasks include IR, TLD Badges, Procurement ,developing and implementing safety protocols, conducting regular safety audits, renewal type approval, managing compliance with regulatory standards, and performing quality checks on radiology equipment. The manager will also provide training and guidance to staff on safety measures and participate in continuous improvement initiatives to enhance service quality. Performing Quality Assurance of various Diagnostic Radiology Equipments as per AERB Test Protocol AERB/RF-MED/SC-3. NABL document preparation, attending audit as per 17025:2017 CDSCO document preparation as per MD9/15 and attending audit BIS documents prepation as per IS 7620 part 1 and attending audit Qualifications Strong knowledge of radiation safety protocols and regulatory compliance Experience in quality assurance and quality control in radiology services Proficiency in conducting safety audits and developing safety training programs Excellent organizational and management skills Ability to work independently and manage a team Bachelor's degree in Radiology, Medical Physics, or related field; RSO certification required Experience in the healthcare industry, particularly in radiology, is a plus
Sales Executive ( X-ray / CR / DR) Edusoft Healthcare is seeking a dynamic and result-oriented Sales Executive to expand our radiology business portfolio, including X-ray machines, CR systems, DR detectors with at least 3 years of experience.
Company Description Edusoft Healthcare Limited is at the forefront of healthcare innovation, delivering top-notch radiology equipment for better diagnostics and patient outcomes. We are dedicated to redefining radiology excellence through our cutting-edge technology and solutions. Our mission is to enhance patient care and improve diagnostic accuracy. Join us in New Delhi to be part of a dynamic team driving advancements in healthcare. Role Description Job Description – Regulatory Affairs Manager (Radiology Products: X-ray / C-Arm / Mammography) Edusoft Healthcare Limited is looking for a highly skilled and experienced Regulatory Affairs professional to lead compliance and regulatory approvals for our expanding range of radiology products, including handheld X-ray systems, surgical C-arms, mammography retrofits, and flat panel detector assemblies. The ideal candidate will be well-versed with NABL, CDSCO (MD-9/MD-15), AERB, BIS/IEC 60601, ISO 13485, and US FDA regulatory frameworks. Key Responsibilities: • Handle end-to-end regulatory compliance for medical devices, including preparation, submission, and renewal of applications with CDSCO, NABL, BIS, AERB, and other authorities. • Ensure timely licensing, certification, and approval for Class B and C radiology devices. • Manage documentation, validation, technical files, and quality management system compliance. Coordinate with internal R&D, production, and quality teams to align processes with regulatory requirements. • Act as company liaison with regulatory bodies, auditors, and certification agencies. • Maintain updated knowledge of changing regulations and guide management on compliance strategies. • Lead audits, inspections, and ensure zero non-compliance findings. Requirements: • Minimum 5–7 years of experience in medical device regulatory affairs, preferably in radiology/X-ray domain. • Strong knowledge of NABL accreditation, CDSCO MD-9/MD-15, BIS standards, ISO 13485, and AERB approvals. • Excellent documentation, communication, and audit-handling skills. • Ability to work independently and drive complete regulatory process successfully Qualifications Proficiency in Regulatory Documentation and maintaining accurate records realted to NABL,CDSCO,ISO 13485,AERB & BIS Strong knowledge of Regulatory Compliance and Regulatory Requirements Experience in managing Regulatory Submissions and ensuring timely approvals Expertise in Regulatory Affairs, including understanding of industry guidelines and standards Excellent organizational and communication skills Ability to work independently and effectively onsite related to all Regulatory requirements Experience in the healthcare or medical device industry is advantageous Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, or related discipline