Anoop Prahalladachar
Senior MDR/Vigilance Specialist | PMP® Certified | Quality & Regulatory Professional
- Role
- Senior Mdr Vigilance Specialist at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Anoop Prahalladachar
I am a results-driven professional with 14+ years of experience in the medical device…
Experience
Senior Mdr Vigilance Specialist
Jul 2022 — Present · Hyderabad, IN
Leading the team of 15 members in Quality and Productivity for diabetic process.• Handling the Internal audit Process for MEIC Diabetic process. • Evaluates incoming complaint information and maintains the record in the electronic database.• Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data on all complaints.• Determines Reportability of complaints and submits Regulatory Reports to Government Agencies.• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.• Writes investigation summaries based on technical product analysis information provided; • Ensures record documentation is maintained in a constant state of audit readiness per internal policies.• Liaison with groups who perform additional investigation and who prepare written record of investigation.• Providing basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.• Reviews and interprets risk management documentation as it applies to the complaint event. • Interacting with multiple departments within Medtronic - RTG, such as Technical Services, Failure Investigation, R&D, Manufacturing and Engineering, as needed, during the course of complaint processing.
Education
S K N Model English High School
Middle School Diploma
2003 — 2004
DVS Composite PU College
High School Diploma, PCMB
2004 — 2006
Visvesvaraya Technological University
Bachelor's degree, Electrical and Electronics Engineering
2006 — 2010
Skills
- Microsoft Office
- Microsoft Excel
- Customer Service
- Powerpoint
- English
- Public Speaking
- Strategic Planning
- Healthcare
- Hospitals
- Management
- Windows
- Medical Devices
- Leadership
- Training
- Negotiation
- Troubleshooting
- Product Development
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