Rohit Kalakanti

Senior Quality Engineer Mdr Vigilance Fda Regulations @美敦力

Hyderabad, IN

Expert in Evaluating the incoming complaint information and maintains the record in the electronic database- SAP systemExpertise in Medical device regulatory (MDR) submissionPerforms 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 by Cross functional teams.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.Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed during the course of complaint processing.Skillfull in all the required trainings and sharing the product knowledge Provide 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.Interacts with multiple departments within Medtronic - RTG, such as Technical Services, Failure Investigation, R&D, Manufacturing and Engineering.Interacts with groups external to Medtronic such as customers, vendors, health care professional.Expert on making Goals set with operations, Manufacturing and Quality leadership programs.

National Institute of Technology Warangal

Bachelor of Technology - BTech, Electrical and Electronics Engineering