Job Title: MDR Vigilance Specialist I
Location: Nanakramguda, Hyderabad
About Medtronic:
Medtronic is a global leader in healthcare technology, committed to alleviating pain, restoring health, and extending life for millions of people around the world. With a diverse portfolio of innovative medical devices and therapies, we are dedicated to improving patient outcomes and transforming healthcare. Join our team and contribute to our mission of making a positive impact on global health.
Job Summary:
Medtronic is seeking a highly motivated and detail-oriented MDR Vigilance Specialist I to join our team in Nanakramguda, Hyderabad. In this role, you will be responsible for supporting medical device vigilance activities, including complaint handling, regulatory reporting, and compliance. Your contributions will directly impact patient safety and product quality by ensuring adherence to global regulatory standards and effective risk management practices. This position offers a unique opportunity to develop your expertise in medical device regulatory affairs and contribute to a company that is at the forefront of healthcare innovation.
Responsibilities:
As an MDR Vigilance Specialist I, you will:
- Evaluate and accurately document incoming complaints in the electronic database.
- Conduct thorough follow-up activities to gather additional information from relevant stakeholders.
- Analyze complaint trends and prepare comprehensive reports for internal and external review.
- Determine the reportability of complaints to government regulatory agencies, such as the FDA, MEDDEV, and Health Canada.
- Develop well-written and detailed Investigation Summaries based on technical product analysis and root cause findings.
- Collaborate effectively with cross-functional teams, including Research & Development, Quality Assurance, Technical Services, Manufacturing, and Engineering.
- Maintain meticulous complaint records in audit-ready condition, ensuring compliance with global regulatory standards.
- Provide technical expertise in medical device complaint handling and risk management processes.
Qualifications:
- Education: Bachelor’s degree in Engineering or Science (preferably Electrical Engineering, Mechanical Engineering, or Biomedical Engineering).
- Experience: 1–3 years of experience in Quality Assurance or Regulatory Affairs within the medical or pharmaceutical industry.
- Technical Skills: Proficiency in MS Word, Excel, Access, and PowerPoint.
- Communication Skills: Strong written communication and technical writing skills.
- Analytical Skills: Ability to multitask, analyze device functionality, and understand complaint trends.
Preferred Skills (Nice to Have):
- Knowledge of FDA, MEDDEV, and Canadian Regulations pertaining to medical devices.
- 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 offers a competitive salary and comprehensive benefits package, including:
- Competitive Salary: Ranging from ₹6,00,000 to ₹10,00,000 per annum (approx.).
- Flexible Benefits Package: A variety of options to meet your individual needs.
- Medtronic Incentive Plan (MIP): Eligibility for performance-based bonuses.
- Career Growth Opportunities: Access to global training programs and advancement opportunities.
Join Medtronic and become part of a team that is dedicated to improving patient lives and making a difference in the world.
To Apply:
If you are a qualified and passionate individual looking for a challenging and rewarding career in medical device regulatory affairs, we encourage you to apply.
