Consumer Affairs Specialist

Location: Carlsbad, California
Posted On: 9/14/2017
Job Code: 4850
Job Description
Preference given to candidates with at least 3 years of experience in Medical Device complaint processing including investigation and regulatory reporting (MDR/MDV).

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.
Category:IT  code:new
Job Requirements
Bachelor degree
•Minimum of 3 years of experience in complaint intake, investigation and regulatory reporting
•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.
•Knowledge of medical devices, their development and quality control.
•Knowledge of FDA, MEDDEV, Canadian Regulations.

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Contact Details
Sitara Verma
E-mail Address