Medical Device Regulatory Affairs Specialist

2 days ago


Kannur, Kerala, India beBeeRegulatory Full time ₹ 16,25,000 - ₹ 24,10,000
Ensure Quality and Regulatory Compliance as a seasoned professional spearheading quality assurance and regulatory affairs for the medical device industry.This is an exciting opportunity to drive compliance, ensure regulatory submissions, and foster continuous improvement in quality systems, regulatory frameworks, and industry standards.The ideal candidate will possess a deep understanding of ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Key Responsibilities:
  • Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with regulatory authorities for permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
  • Manage regulatory submissions and ensure timely approvals.
  • Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
  • Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Profile:
  • Strong understanding of quality systems and regulatory frameworks for medical devices.
  • Hands-on experience with regulatory submissions, PMS, and risk management.
  • Excellent knowledge of GMP, GDP, and ISO 13485 standards.
  • Strong communication, documentation, and coordination skills.


  • Kannur, Kerala, India beBeeDeviceEngineering Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Title: Senior Device EngineerSenior Device Engineer Job RoleThis senior device engineer position is responsible for evaluating and validating medical devices to ensure compliance with regulatory standards.A minimum of 10 years of experience in healthcare products or a related field, encompassing research and development, manufacturing, quality...


  • Kannur, Kerala, India beBeeDesign Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Mechanical Design Architect RoleWe are seeking a skilled Design Engineer driven by the passion to enhance patients' lives through groundbreaking medical devices.As a Mechanical Architect in the medical device domain, you will lead the development of innovative technologies that tackle complex healthcare challenges. Your design engineering expertise will be...


  • Kannur, Kerala, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 30,00,000

    We are seeking an experienced professional to join our team as a Regulatory Affairs Expert.Job Title: Regulatory Affairs SpecialistLocation: RemoteMain Responsibilities:The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and...


  • Kannur, Kerala, India beBeeBiomedical Full time ₹ 50,00,000 - ₹ 80,00,000

    Healthcare Innovation RoleThe field of biomedical engineering is a dynamic fusion of science and technology, focused on developing innovative solutions for healthcare applications. This multidisciplinary approach combines knowledge of biology, chemistry, physics, and materials science to improve patient care and outcomes.In this critical role, the successful...


  • Kannur, Kerala, India beBeeCompliance Full time US$ 60,000 - US$ 96,000

    Business Compliance and Registration Specialist Job Summary:We are seeking a dedicated Business Compliance and Registration Specialist to assist companies with their business formation and registration processes. This role involves handling federal registrations, state and local tax registrations, payroll setups, and managing ongoing regulatory...


  • Kannur, Kerala, India beBeeEditor Full time ₹ 15,00,000 - ₹ 18,00,000

    Medical Editor Job Summary:We are seeking an experienced Medical Editor to join our team. The successful candidate will be responsible for reviewing, editing and ensuring the quality and accuracy of medical and scientific documents.The ideal candidate will have a strong background in life sciences and experience working with pharmaceutical companies. They...


  • Kannur, Kerala, India beBeeMedicalRecordSpecialist Full time ₹ 4,00,000 - ₹ 8,00,000

    Medical Record SpecialistThis role is responsible for maintaining accurate and secure patient medical records in compliance with regulatory requirements.The Medical Record Specialist will work closely with healthcare providers to ensure timely and accurate completion of medical records and documentation.Key Responsibilities:Create and maintain electronic or...


  • Kannur, Kerala, India beBeeBiomedical Full time ₹ 8,00,000 - ₹ 12,00,000

    Biomedical Engineering ManagerAn exciting opportunity has arisen for a Biomedical Engineering Manager to join our team. As a key member of the biomedical engineering department, you will play a critical role in overseeing the planning, implementation, and maintenance of biomedical equipment and systems within a healthcare facility.Your primary responsibility...


  • Kannur, Kerala, India beBeeTechnical Full time ₹ 9,00,000 - ₹ 12,00,000

    Immunodiagnostics Documentation SpecialistJob Title: Immunodiagnostics Documentation SpecialistLocation: Remote (Hybrid)Role Overview:We are seeking a skilled Documentation Specialist to develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products, including IFUs, user manuals, product labels, and digital learning aids.Key...


  • Kannur, Kerala, India beBeeMedicalDevices Full time ₹ 18,00,000 - ₹ 24,00,000

    Medical Devices Quality Assurance RoleAbout the PositionWe are seeking a seasoned Medical Devices Quality Assurance professional to join our team.The ideal candidate will have extensive experience in quality management, risk assessment, and regulatory compliance within the medical devices industry.Key ResponsibilitiesEnsure adherence to ISO 13485, MDD...