Medical Device Compliance Specialist

1 week ago


Hyderabad, Telangana, India Medtronic Full time

Medtronic - A Career that Impacts Lives

We are seeking a highly skilled Medical Device Compliance Specialist to join our team.

About the Role

This is a critical position responsible for ensuring compliance with regulatory requirements and guidelines related to medical devices. The successful candidate will have a strong background in quality assurance, regulatory experience, and excellent analytical skills.

Key Responsibilities

  • Evaluate and classify product complaints related to medical devices, including review of technical product analysis information provided by the plant.
  • Determine reportability of complaints to government agencies, such as the FDA.
  • Maintain accurate records in electronic databases and provide analysis and trending data on complaints.
  • Liaise with cross-functional teams, including Technical Services, Manufacturing, R&D, and Quality Assurance.
  • Provide technical expertise and assistance in handling complaints to ensure compliance with current regulations.

Requirements

  • Bachelor's degree in a relevant field, such as Engineering or Science.
  • 4-8 years of experience in quality assurance or regulatory roles within the medical or pharmaceutical industry.
  • Excellent communication and analytical skills, with ability to multitask and work in a team environment.
  • Strong typing skills and ability to write business documents with minimal supervision.

What We Offer

As a Medical Device Compliance Specialist at Medtronic, you can expect a competitive salary range of $85,000-$110,000 per year, depending on experience, plus a comprehensive benefits package and opportunities for professional growth and development.



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