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Vigilance Specialist

3-8 years

Hyderabad / Secunderabad

Vigilance Specialist

Cyient

posted 8d ago

Job Role Insights

Flexible timing

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

Read full job description

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Q1. Introduction. Difference between Embedded Systems and Embedded software. Difference between linux and windows. Why use microcontroller inste ... read more
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What people at Cyient are saying

What Cyient employees are saying about work life

based on 4.5k employees
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93%
57%
88%
Flexible timing
Monday to Friday
No travel
Day Shift
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Cyient Benefits

Team Outings
Soft Skill Training
Cafeteria
Job Training
Health Insurance
Work From Home +6 more
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Cyient Hyderabad / Secunderabad Office Locations

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Hyderabad Office
Headquarter
Cyient Ltd. - Uppal, NSL SEZ ARENA, 9th Floor, Block-6, Survey No-1, Plot No. 6, Uppal - Ramanthapur Rd, Uppal Hyderabad
Telangana 500039
Hyderabad Office
Cyient Ltd, Plot no-2, IT Park,ISB Road, Nanakramguda, Gachibowli, Near Continental Hospital Hyderabad
Telangana 500032

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