Field Assurance Manager

What does a typical day look like?

* Receive complaints and follow-up to collect relevant information from the user.
* Arrange for the return of complaints samples.
* Direct the investigation of complaints including any bench testing.
* Review existing P/DFMEAs for updates, as required.
* Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate, arrange for a HHE by a medical professional.
* Determine whether a product malfunction or serious injury report needs to be filed with the FDA.
* Where a complaint should be an MDR, file the necessary report with the FDA within required time frames.
* Evaluate potential MDRs, conduct a risk analysis and obtain a HHE, when necessary.
* Where necessary, handle FDA inquires of complaints.
* Interacts with international facilities with reporting responsibilities to BMD in establishing standardization of complaint handling and MDR/vigilance compliance.
* Approve all International Vigilance decision trees.
* Where the complaint should be a Competent Authority Report, create the vigilance report, if required, provide any CA inquiries.
* Maintain all required records for the complaints and/or MDR Reports.
* Where necessary, assign CAPA investigation.
* Train customer facing staff, such as sales staff, on the complaint system and internal reporting procedure.
* Lead training on GMPs/complaint handling for sales representatives.
* When sales training materials involve questions of safety or indications, review and approve the sales force training materials.
* Approve the protocol for any post market surveillance study or evaluation.
* Review and approve interim and final reports of a post market surveillance study.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services.  Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit Aerotek.com.