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Vigilance Specialist

3-8 years

Hyderabad / Secunderabad

Vigilance Specialist

Cyient

posted 9d ago

Job Description

  • 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.
  • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
  • 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 - RTG, such as customers, vendors, health care professional

 

Minimum Qualifications

 

  • Bachelor degree; Engineering or Science degrees preferred (e.g. ECE, Biomedical Engineering, ME)
  • 4-8 years quality assurance or regulatory experience in medical or pharmaceutical industry.
  • Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis
  • Strong typing skills and ability to write business documents with minimal supervision.
  • Strong verbal and written communication skills and ability to work in a team oriented environment
  • Ability to multitask.
  • Ability to understand the functionality / intended use of complex medical devices.
  • Minimum travel may be required 

 

Nice to Haves

 

  • Knowledge of medical devices, their development and quality control.
  • Knowledge of medical device standards.
  • Knowledge of FDA, MEDDEV, Canadian Regulations.
  • Technical Writing experience.  

Employment Type: Full Time, Permanent

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