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Medical Device Regulatory Specialist

1 week ago

Hyderabad, Telangana, India Medtronic Full time

We lead global healthcare technology at Medtronic, boldly attacking the most challenging health problems facing humanity. As a Medical Device Regulatory Specialist, you'll play a crucial role in championing healthcare access and equity for all.

About the Job

You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. Your day will involve reviewing and evaluating product complaints related to medical devices, classifying complaints, and performing follow-up activities.

Your Key Responsibilities:

  • Evaluate incoming complaint information and maintain records in the electronic database
  • Perform follow-up activities to obtain additional information
  • Use and maintain database skills to provide analysis and trending data on complaints
  • Determine reportability of complaints to Government Agencies
  • Identify and document appropriate complaint categories to ensure trend accuracy
  • Write investigation summaries based on technical product analysis information
  • Ensure record documentation is maintained in a state of audit readiness
What You Need to Succeed

To excel in this role, you'll require:

  • Bachelor's degree in Engineering (e.g., SW, EE, ME, Biomedical Engineering)
  • 4-8 years of quality assurance or regulatory experience in the medical or pharmaceutical industry
  • Strong typing skills and ability to write business documents with minimal supervision
  • Strong verbal and written communication skills and ability to work in a team-oriented environment
  • Ability to multitask and understand complex medical device functionality