QA/ QC- NABL

4 days ago

New Delhi, India Edusoft Healthcare Limited Full time

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

  • QA/ QC- NABL

    4 days ago

    new delhi, India Edusoft Healthcare Limited Full time

    Company DescriptionEdusoft 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...

  • QA/ QC- NABL

    4 days ago

    New Delhi, India Edusoft Healthcare Limited Full time

    Company DescriptionEdusoft 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...

  • QA/ QC- NABL

    4 days ago

    New Delhi, India Edusoft Healthcare Limited Full time

    Company DescriptionEdusoft 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...

  • QA/qc - Paf

    1 week ago

    Delhi, India Larsen & Toubro Limited Full time

    Liaise with the Engineer/Customer on the quality related activities of the project. - Ensure the following through the project Materials function: - Liaise for Approvals for concrete mix design, aggregate base course materials and granular sub base materials. - Liaise for laboratory equipment’s for verifying properties of materials complying with the...

  • QA/QC Executive

    3 days ago

    Delhi, India The Hiring Company Full time

    Job Title: QA/QC ExecutiveLocation: Bandra East, MumbaiSalary: Up to ₹20,000 per monthAbout the RoleWe are seeking a QA/QC Executive to join our team. The role primarily involves document validation, quality checks, and ensuring accuracy across various processes. Candidates must be detail-oriented, reliable, and capable of maintaining high standards of...

  • QA/QC Executive

    2 days ago

    Delhi, India The Hiring Company Full time

    Job Title: QA/QC Executive Location: Bandra East, Mumbai Salary: Up to ₹20,000 per month About the Role We are seeking a QA/QC Executive to join our team. The role primarily involves document validation, quality checks, and ensuring accuracy across various processes. Candidates must be detail-oriented, reliable, and capable of maintaining high standards...

  • QA/QC Executive

    2 days ago

    Delhi, India The Hiring Company Full time

    Job Title: QA/QC ExecutiveLocation: Bandra East, MumbaiSalary: Up to ₹20,000 per monthAbout the RoleWe are seeking a QA/QC Executive to join our team. The role primarily involves document validation, quality checks, and ensuring accuracy across various processes. Candidates must be detail-oriented, reliable, and capable of maintaining high standards of...

  • Qa/qc Engineer

    2 weeks ago

    Delhi, Delhi, India Continental HR Solutions Full time

    Job : QA/QC Engineer (Welding & Coating)Department: Quality Assurance / Quality Control Salary Package - 500 to 700 Omani Rial ( Rs.114000 - 160399 Indian Rupee)Qualifications & Experience Bachelor's or Diploma in Mechanical Engineering or Chemical Engineering.Minimum of 6 years' experience in quality control and assurance roles within the oil & gas...

  • QA/QC Engineer

    3 weeks ago

    Delhi, Delhi, India Continental HR Solutions Full time

    Job : QA/QC Engineer (Welding & Coating) Department: Quality Assurance / Quality Control Salary Package - 500 to 700 Omani Rial ( Rs. - Indian Rupee) Qualifications & Experience Bachelor's or Diploma in Mechanical Engineering or Chemical Engineering. Minimum of 6 years' experience in quality control and assurance roles within the oil & gas industry....

  • QA/QC Engineer

    2 weeks ago

    Delhi, Delhi, India Continental HR Solutions Full time

    Job : QA/QC Engineer (Welding & Coating)Department: Quality Assurance / Quality ControlSalary Package - 500 to 700 Omani Rial ( Rs. 114000 - 160399 Indian Rupee)Qualifications & ExperienceBachelor's or Diploma in Mechanical Engineering or Chemical Engineering.Minimum of 6 years' experience in quality control and assurance roles within the oil & gas...