Medical Devices Regulatory Specialist

2 days ago


Coimbatore, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Affairs Manager Job Description

We are seeking an experienced Regulatory Affairs Manager to join our team. The ideal candidate will have a strong understanding of quality systems and regulatory frameworks.

  • Key Responsibilities:
  • Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Coordinate with local authorities for obtaining permissions and approvals.
  • Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for 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.
Requirements
  • Education: B.Pharm/M.Pharm (Relevant experience in Medical Device Industry required)
  • Experience: 5-7 Years
  • Skills:
    • Strong understanding of quality systems and regulatory frameworks.
    • 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.
Benefits

The successful candidate will enjoy a challenging and rewarding career path with opportunities for professional growth and development.

Other Opportunities

This role offers the chance to work on exciting projects and collaborate with a talented team of professionals.



  • Coimbatore, Tamil Nadu, India beBeeHardware Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

    Medical Device Hardware Design SpecialistWe are seeking an experienced Medical Device Hardware Design Specialist to join our team.At our organization, we aim to revolutionize healthcare by developing innovative medical device solutions. Our team collaborates with experts from diverse fields to bring cutting-edge technologies that enhance healthcare and...


  • Coimbatore, Tamil Nadu, India beBeeMechanical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Lead Mechanical DesignerDrive innovation in medical device design by joining our team of visionary engineers. We are seeking an experienced Lead Mechanical Designer to develop advanced mechanical systems for next-generation medical devices.This pivotal role involves conceptualizing, designing, developing, and optimizing mechanical systems and sub-systems...


  • Coimbatore, Tamil Nadu, India Bosch Full time

    Company Description Bosch Global Software Technologies Private Limited is a 100 owned subsidiary of Robert Bosch GmbH one of the world s leading global supplier of technology and services offering end-to-end Engineering IT and Business Solutions With over 28 200 associates it s the largest software development center of Bosch outside Germany ...


  • Coimbatore, Tamil Nadu, India beBeeSupplyChain Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Job OverviewWe are seeking a detail-oriented professional to support end-to-end supply chain operations in the medical device industry. Our ideal candidate will have strong knowledge of FDA, ISO 13485, and CE standards, as well as experience with supplier quality management, NC/CAPA processes, and risk management.Key Responsibilities:Develop and execute...


  • Coimbatore, Tamil Nadu, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000

    Ensure regulatory compliance and drive product development with our team.Job OverviewThe ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization.Prepared, reviewed, and submitted regulatory filings, including...


  • Coimbatore, Tamil Nadu, India beBeeScientific Full time ₹ 10,00,000 - ₹ 16,00,000

    Medical Content SpecialistWe are seeking a highly skilled medical content specialist to join our team. This is an exciting opportunity for an experienced writer with a background in medical science to combine their passion for writing with their expertise in scientific communication.Key Responsibilities:Develop high-quality scientific, medical, and...


  • Coimbatore, Tamil Nadu, India beBeeCoding Full time ₹ 1,04,000 - ₹ 1,30,878

    Medical Coding SpecialistAs a medical coding specialist, you will play a crucial role in ensuring the accuracy and consistency of medical records.The core responsibility of a medical coder is to review clinical statements and assign standardized codes to diagnoses, procedures, and services.Coders must have a thorough understanding of healthcare diagnosis,...


  • Coimbatore, Tamil Nadu, India beBeeEmbedded Full time ₹ 20,00,000 - ₹ 25,00,000

    Embedded Hardware EngineerAbout the Role:We are seeking an experienced Embedded Hardware Design Engineer with expertise in miniaturizing wearable devices. The ideal candidate will have a strong background in RF design, impedance matching, and wireless power transmission systems.Key Responsibilities:Lead end-to-end hardware design for wearable devices, from...


  • Coimbatore, Tamil Nadu, India beBeeCompliance Full time

    We are seeking a skilled Medical Coding Specialist to join our organization. The ideal candidate will have experience in medical coding and a passion for accuracy and compliance.Job OverviewThe successful applicant will be responsible for accurately coding medical records in compliance with industry standards, ensuring timely and efficient performance....


  • Coimbatore, Tamil Nadu, India beBeeGovernment Full time ₹ 9,00,000 - ₹ 15,00,000

    Job Title: Government Regulatory Affairs Specialist">Job Summary:We are seeking a skilled professional to build and maintain relationships with government officials and regulatory bodies, ensuring our organization's compliance with relevant laws and regulations.This role requires strong communication, negotiation, and relationship-building skills, as well as...