Regulatory Affairs Officer

2 days ago

Delhi, Delhi, India Edusoft Healthcare Limited Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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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