Consumer Affairs Specialist

Location: Carlsbad, California
Posted On: 6/5/2017
Job Code: Cons_aff_spec_carlsb
Job Description
Summary of Position:
Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.

Essential Functions:
•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 all on complaints.
•Determines Reportability of complaints to Government Agencies.
•Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
•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.

•Bachelor’s degree
•Minimum of 2 year+ quality assurance or regulatory experience in medical or pharmaceutical industry
•Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis and office equipment (copier, fax machine)
•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.
Category:Non-IT  code:new
Job Requirements
MS Access, MS Excel, Management, Quality Assurance, MS Word, Risk Management

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Contact Details
Chirag Sharma
E-mail Address