Medical Device Compliance Expert

2 days ago


Aligarh, Uttar Pradesh, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000

Job Overview

As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of medical devices in accordance with regulatory standards.

Key Responsibilities:

  • Implement and maintain a Quality Management System (QMS) to ensure products meet quality, safety, and regulatory standards.
  • Identify, interpret, and ensure adherence to relevant medical device regulations for market entry and ongoing compliance.
  • Create, review, and control technical files, regulatory submissions, quality agreements, and internal procedures.
  • Provide QA/RA input and support for design and development activities to ensure compliance from the outset.
  • Participate in risk management activities throughout the product life cycle to identify and mitigate potential hazards.
  • Monitor device performance in the market, investigate customer complaints and non-conformity, and manage vigilance reporting.
  • Support the management of supplier quality and compliance.
  • Conduct internal audits and lead initiatives to improve processes and ensure adherence to QMS requirements.

Requirements:

  • Deep knowledge of global medical device regulations and standards.
  • Excellent problem-solving and attention to detail skills.
  • Strong communication skills to coordinate with internal departments and external stakeholders.
  • Bachelor's degree in a relevant field such as engineering, life sciences, or a related technical discipline.
  • Previous experience in QA/RA within the medical device industry is an advantage.


  • Aligarh, Uttar Pradesh, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 25,00,000

    Medical Device Quality Assurance and Regulatory Affairs LeadWe are seeking an accomplished professional to spearhead our efforts in ensuring the quality and regulatory compliance of medical devices.This role entails overseeing the implementation of quality management systems, managing regulatory submissions, and ensuring timely approvals. The ideal candidate...


  • Aligarh, Uttar Pradesh, India beBeeSenior Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Description:As a Senior Medical Device Engineer, you will have the opportunity to work in a dynamic environment and utilize your technical expertise to assess and audit medical devices.">Responsibilities include:Conducting thorough assessments of medical devices to ensure compliance with industry standards such as ISO 13485 and MDD...


  • Aligarh, Uttar Pradesh, India beBeeTechnician Full time ₹ 10,000 - ₹ 15,000

    Expert Medical Device Technician SoughtJob OverviewWe are currently seeking an experienced medical device technician to oversee the efficient turnaround of medical devices at our facility.Key Responsibilities:Perform thorough disinfection and cleaning of medical devices in accordance with established SOPs.Conduct inspections to identify functional issues...


  • Aligarh, Uttar Pradesh, India beBeeEngineering Full time ₹ 12,00,000 - ₹ 18,00,000

    Job Overview:Skillful engineers with extensive experience in medical device development and quality assurance are highly sought after to lead our team forward.Responsibilities:Lead the development of medical devices through research, manufacturing, quality management, and regulatory compliance.Ensure adherence to international quality standards including ISO...


  • Aligarh, Uttar Pradesh, India beBeeBiomedical Full time ₹ 15,00,000 - ₹ 20,00,000

    Biomedical Equipment SpecialistThis role involves installing, inspecting, calibrating, maintaining and repairing medical equipment used for patient care.Equipment includes patient monitors, ventilators, X-ray machines and ultrasound devices.The specialist ensures these devices are safe, accurate and functioning correctly to support diagnosis and treatment.To...


  • Aligarh, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs professional to join our team. This is an exciting opportunity for someone with expertise in both pharmaceutical and medical device regulatory compliance.The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and...


  • Aligarh, Uttar Pradesh, India beBeeBiomedical Full time ₹ 15,00,000 - ₹ 20,00,000

    As a Biomedical Specialist, you will be responsible for ensuring the optimal functioning of medical equipment.This role involves working closely with clinical engineering teams to guarantee that all devices meet strict safety and performance standards.The ideal candidate will possess expertise in biomedical engineering principles and have experience in...


  • Aligarh, Uttar Pradesh, India beBeeOpcenter Full time ₹ 90,00,000 - ₹ 1,20,00,000

    We are seeking a highly skilled professional to lead the implementation and upgrading of Opcenter Execution Medical Device and Diagnostics systems.The ideal candidate should have expertise in system installations, interface configuration, data migrations, and infrastructure understanding, ideally within regulated environments.Key Responsibilities:Perform...


  • Aligarh, Uttar Pradesh, India beBeeCoding Full time ₹ 10,00,000 - ₹ 15,00,000

    Medical Coding ExpertWe seek a seasoned medical coder with expertise in surgery coding, including outpatient and professional procedures. This role requires a strong understanding of clinical concepts and the ability to apply coding principles to extract data from medical documents.Responsibilities:Apply clinical information to understand payer processes for...


  • Aligarh, Uttar Pradesh, India beBeeDevelopment Full time ₹ 1,60,80,000 - ₹ 2,41,20,000

    Device Development LeadThis is a unique opportunity for an experienced professional to lead the development of device and drug combination products in our company.The ideal candidate will have a degree in engineering and around 12 years of experience in medical device characterization.Key responsibilities include leading device workstreams, developing new...