Buna Anil

About Buna Anil

Quality and Regulatory affairs professional with 14+ years of experience in the medical…

Experience

1. Senior Medical Device Regulatory Vigilance Specialist

   美敦力

   Jul 2022 — Present · Hyderabad, IN

   Led a team of 20 members in driving Quality and Productivity for diabetic complaint handling processes.Managed the EU MDR Regulatory Reporting Process as Subject Matter Expert, enhancing efficiency and accuracy.Assumed accountability for implementing the most recent updates and instructing the team on adhering to instructions from governing bodies.Implemented and managed a database system for tracking and analyzing Late MDR.Enhanced process efficiency, monitoring, and reporting using created and maintained tracking spreadsheets.Recommended improvements to business requirements or procedures to align with competent authority regulatory mandates.Generated detailed reports with findings and recommendations for evaluating staff defects.Collected, arranged, and inputted complaint information into the database system. Evaluated incoming complaint information and maintained records in the electronic database. Conducted follow-up activities to obtain additional information.Determined complaint reportability and submitted Regulatory Reports to Government Agencies.Wrote investigation summaries using technical product analysis information and initial case notes.Maintained constant audit readiness for record documentation according to internal policies while collaborating with Medtronic departments including Technical Services, Failure Investigation, R&D, Manufacturing, and Engineering in complaint processing.Attended training programs to enhance professional skills and assisted in training fellow associates on new and existing programs.Adhered to company policies and procedures to consistently deliver quality work. Stayed updated on market conditions, compliance standards, and best practices.

Education

• JB Institute of Engineering & Technology

  B-Tech

  2006 — 2010

Skills

• Biotechnology
• Research and Development (R&D)
• Biomedical Engineering
• Hardware Diagnostics
• Matlab
• Medical Devices
• Nanotechnology
• Lifesciences
• Healthcare
• Microsoft Office
• Biomechanics
• Labview
• R&D
• Radiology
• Healthcare Information Technology (Hit)
• Ultrasound
• Medical Imaging
• Hospitals