Medical Device Compliance Specialist

2 days ago


Hyderabad, Telangana, India Medtronic Full time

Medtronic is a leader in medical technology, offering innovative solutions for patients and healthcare professionals. We are seeking a highly skilled individual to join our team as a Medical Device Compliance Specialist.

Estimated Salary: $80,000 - $110,000 per year

Job Description:

As a Medical Device Compliance Specialist, you will play a critical role in ensuring that our medical devices meet the highest standards of quality and safety. Your responsibilities will include:

  • Reviewing and evaluating product complaints to identify potential issues with device performance or safety;
  • Evaluating complaint information and determining whether it meets reporting criteria for government agencies;
  • Writing investigation summaries based on technical product analysis information provided by our plant;
  • Liaising with internal teams, including Technical Services, Manufacturing, R&D, and Quality Assurance, to resolve complaint-related issues;
  • Providing technical expertise and assistance in handling complaints to comply with FDA and international regulations;
  • Interpreting risk management documentation related to complaint events;
  • Collaborating with external stakeholders, including customers, vendors, and healthcare professionals.

Required Skills and Qualifications:

To be successful in this role, you will need:

  • A Bachelor's degree in Engineering or a Science discipline, such as Biomedical Engineering;
  • 4-8 years of experience in quality assurance or regulatory affairs within the medical or pharmaceutical industry;
  • Strong typing skills and ability to write business documents with minimal supervision;
  • Excellent verbal and written communication skills, with the ability to work effectively in a team-oriented environment;
  • Ability to multitask and prioritize multiple projects simultaneously;
  • Strong analytical and problem-solving skills, with the ability to interpret complex data and make informed decisions.

Benefits:

We offer a competitive compensation package, including a base salary, bonuses, and comprehensive benefits. You will also have opportunities for professional growth and development within a dynamic and innovative organization.



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