Robert Half Technology Consumer Affairs Specialist in Carlsbad, California
CARLSBAD – Robert Half is working with a Global Healthcare Company who is seeking a Consumer Affairs Specialist on a long-term temporary basis. This position will 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 death or serious injury. Responsibilities will include: - 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. - 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. This position is expected to begin as soon as the right candidate is found and will require all work to be onsite at the Client's location in Carlsbad, California for 5+ months. Successful candidates should have a Bachelor's Degree and 3 or so years of experience in Medical Device complaint processing including investigation and regulatory reporting (MDR/MDV) and experience in complaint intake, investigation and regulatory processing. For immediate consideration, please forward your resume in WORD format to firstname.lastname@example.org.
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Req ID: 04860-9500777272
Functional Role: Account Executive/Staffing Manager
Postal Code: 92008
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.
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.