The Field Assurance Specialist (FA) is responsible for managing the complaint handling and reporting processes for devices that have been approved for distribution.
The Field Assurance Specialist (FA) initiates domestic and/or OUS complaints, gathers event information, determines reportability per FDA regulations, submits regulatory reports, and provides feedback to the customer, if appropriate. The FA Specialist also provides complaint detail to management, project teams and engineering, as requested.
Bachelor’s degree in technical field and 0-1 years experience in healthcare/medical device manufacturing environment.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.