Medtronic, a global leader in healthcare technology, is inviting applications for the MDR Vigilance Specialist I position in Nanakramguda, Hyderabad. This role offers an exciting opportunity to contribute to medical device vigilance, complaint handling, and regulatory compliance, ensuring patient safety and product quality.
If you hold a background in Biomedical Engineering, Electronics, or Quality Assurance, this position can be your gateway into a thriving career in medical device regulatory affairs.
Key Responsibilities
As an MDR Vigilance Specialist I, you will:
- Evaluate and document incoming complaints in the electronic database.
- Perform follow-up activities to gather additional information from stakeholders.
- Analyze complaint trends and prepare detailed reports for internal and external review.
- Determine reportability of complaints to government regulatory agencies (e.g., FDA, MEDDEV, Health Canada).
- Write Investigation Summaries based on technical product analysis and root cause findings.
- Collaborate with cross-functional teams – R&D, Quality Assurance, Technical Services, Manufacturing, and Engineering.
- Maintain complaint records in audit-ready condition, ensuring compliance with global regulatory standards.
- Provide technical expertise in medical device complaint handling and risk management.
Required Qualifications
- Education: Bachelor’s degree in Engineering or Science (preferably EE, ME, or Biomedical Engineering).
- Experience: 1–3 years in Quality Assurance or Regulatory Affairs within the medical or pharmaceutical industry.
- Proficiency in MS Word, Excel, Access, and PowerPoint.
- Strong written communication and technical writing skills.
- Ability to multitask, analyze device functionality, and understand complaint trends.
Preferred Skills (Nice to Have)
- Knowledge of FDA, MEDDEV, and Canadian Regulations.
- Experience with medical device development and quality systems.
- Familiarity with ventilators and biomedical equipment, including electronics, sensors, and software-driven systems.
- Exposure to technical writing and risk management documentation.
Benefits & Compensation
Medtronic provides a competitive salary and flexible benefits package, along with eligibility for the Medtronic Incentive Plan (MIP).
Employees enjoy career growth opportunities, access to global training programs, and the chance to contribute to Medtronic’s mission — to alleviate pain, restore health, and extend life.
💰 Expected Salary Range: ₹6,00,000 – ₹10,00,000 per annum (approx.)
How to Apply
