MDR Vigilance Specialist – Medical Devices
Location: Nanakramguda, Hyderabad, India | Flexible Work Arrangement
Employment Type: Full-Time
Experience Level: Mid-level
About Medtronic
Medtronic is a global leader in healthcare technology, dedicated to improving patient outcomes, championing healthcare access, and driving innovation across the medical device industry. With over 95,000 employees worldwide, we engineer solutions that alleviate pain, restore health, and extend life.
Join a company where your work impacts millions of patients globally, and where exploration, innovation, and collaboration are valued at every level.
Role Overview
The MDR Vigilance Specialist plays a critical role in monitoring, evaluating, and reporting medical device complaints to ensure compliance with FDA and international regulations. The role involves thorough analysis of incoming complaints, trend evaluation, technical investigation, and collaboration across multiple departments to maintain device safety and quality.
Key Responsibilities
Review, classify, and evaluate all product complaints related to identity, quality, reliability, safety, and effectiveness of medical devices.
Determine reportability of complaints to government agencies (e.g., FDA, international authorities).
Maintain electronic complaint databases, ensuring data is complete, accurate, and audit-ready.
Conduct follow-up activities to obtain additional information and ensure thorough documentation.
Write investigation summaries based on technical product analysis.
Liaise with Technical Services, R&D, Manufacturing, Quality Assurance, and external stakeholders during complaint handling.
Provide basic technical expertise and guidance to ensure compliance with regulatory reporting requirements.
Analyze and interpret risk management documentation in relation to complaint events.
Identify trends, categorize complaints accurately, and support continuous improvement in complaint handling processes.
Required Knowledge and Experience
Demonstrated experience in medical device vigilance, complaint management, or regulatory affairs.
Strong knowledge of FDA and international medical device reporting regulations (MDR, ISO 13485, etc.).
Ability to evaluate complaints and determine if they indicate potential death or serious injury risks.
Proficient in maintaining electronic databases and generating trend reports and analytics.
Strong communication and collaboration skills, working effectively with cross-functional teams and external stakeholders.
Why Medtronic
Competitive salary and flexible benefits package.
Eligible for Medtronic Incentive Plan (MIP) for performance-based rewards.
Opportunity to work in a global, innovative environment with cutting-edge medical technologies.
Career growth through exposure to R&D, quality, regulatory affairs, and post-market vigilance.
Be part of a culture that values diversity, inclusion, and innovation, empowering employees to make a real difference.
Physical & Other Requirements
The role may require interaction across departments and locations; flexibility in work approach is expected.
Must maintain accuracy and audit readiness for all complaint documentation.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Swords |Republic of China :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Athens | Koropi |Greece :
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Auckland |New Zealand :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Tel Aviv | Netanya | Be'Er Sheva | Kfar Saba | Yavne |Remote :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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