Job Title:
MDR Vigilance Specialist II
Company:
Medtronic
Location:
Nanakramguda, Hyderabad, India
Job Type:
Full-time (Hybrid, as per Medtronic's usual model)
Job Summary:
As an MDR Vigilance Specialist II at Medtronic, you will evaluate and classify product complaints related to the safety, quality, and effectiveness of medical devices. You'll determine the reportability of events to government agencies and collaborate with various internal teams to support compliance and vigilance activities.
Key Responsibilities:
Evaluate and classify product complaints in electronic systems.
Perform follow-ups to gather additional information.
Analyze complaint trends and generate reports.
Determine whether complaints are reportable to regulatory agencies (FDA, EU, etc.).
Assign accurate complaint categories to ensure data trend accuracy.
Write investigation summaries based on technical analysis.
Ensure audit-ready documentation in compliance with internal policies.
Liaise with cross-functional teams (Technical Services, QA, R&D, Manufacturing).
Provide basic technical and regulatory support regarding complaint handling.
Interpret risk management documentation relative to complaint events.
Interact with external parties such as customers, vendors, and healthcare professionals.
Assist or mentor entry-level professionals in the team when needed.
Career Stream Level:
Specialist
Independent contributor with moderate supervision.
Focuses on completing complex projects and influencing outcomes across departments.
May mentor junior staff or provide support in collaborative assignments.
Minimum Qualifications:
Bachelor’s degree in Engineering or Life Sciences (e.g., Biomedical, Mechanical, Electrical).
4 to 8 years of experience in Quality Assurance or Regulatory Affairs within medical or pharmaceutical industry.
Strong computer skills: MS Word, Excel, Access, PowerPoint, and complaint tracking databases.
Proficient in business communication and documentation.
Excellent verbal and written communication.
Strong organizational and multitasking skills.
Ability to understand the use and functionality of complex medical devices.
Nice to Have:
Knowledge of FDA, MEDDEV, and Canadian regulatory requirements.
Prior experience in technical writing.
Familiarity with medical device development and quality control processes.
Physical Job Requirements:
Minimal travel may be required.
Must be capable of working in an audit-ready, documentation-focused environment.
Benefits & Compensation:
Competitive salary and flexible benefits package.
Opportunities for growth through award-winning training and career development programs.
Recognition programs and inclusive workplace culture.
About Medtronic:
Medtronic is a global healthcare technology leader with a mission to alleviate pain, restore health, and extend life. With over 95,000 employees worldwide, Medtronic innovates at the intersection of biology and engineering to solve the world’s most challenging health problems.
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