
Regulatory Affairs Officer
1 day ago
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
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