MDR/Vigilance Specialist II

3 days ago


Hyderabad, Telangana, India Medtronic Full time

Careers that Change Lives

Job Summary

We are seeking a highly skilled and detail-oriented Device Safety Specialist to join our team at Medtronic. As a key member of our quality assurance team, you will play a critical role in ensuring the safety and effectiveness of our medical devices.

Key Responsibilities

  • Evaluate and classify product complaints related to the identity, quality, reliability, safety, and effectiveness of medical devices.
  • Determine the reportability of complaints to government agencies and ensure compliance with FDA and international regulations.
  • Write investigation summaries based on technical product analysis information provided by the plant.
  • Liaise with internal departments, including Technical Services, Manufacturing, R&D, and Quality Assurance, to ensure timely and accurate complaint resolution.
  • Provide basic technical expertise and assistance in handling complaints to comply with current regulations.

Requirements

  • Bachelor's degree in Engineering or Science (e.g. SW, EE, ME, Biomedical Engineering) preferred.
  • 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.


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