Clinical Complaint Specialist Zeltiq Aesthetics, Inc.

Description



Summary:

Responsible for the investigation and closure of clinical complaints globally. Also responsible for the monitoring of clinical trends through the complaint-handling process. Responsible for responding to clinical inquiries from physician users, patients or distributors.

Essential Duties and Responsibilities include the following (other duties may be assigned):

Receive and investigate all clinical complaints from physician users, patients or distributors.

Gather clinical information pertinent to each complaint and document in the SAP system.

Ensure timely complaint investigation, escalation and closure. Complete clinical complaint reports using FilePro Maker in a timely fashion upon closure.

Interface with complainants, Customer Service, Quality, Sales/STEP, Clinical departments as needed.

Assist with initial assessment of complaints for Medical Device Reporting and other regulatory reporting requirements.

Assist in general compliance activities as required.

Provide input to support the continual improvement of complaint handling processes.

Monitor clinical complaint occurrences and trends through the clinical complaint system. Identify any changes in the nature, severity, or frequency of side effects or other clinical complaints. Provide input into the identification of the root-cause of complaints.

Respond to clinical inquiries from physician users, patients or distributors in a timely fashion, in consultation with other resources, such as Clinical, Research and Development, as needed.

Perform all duties in accordance with the Company?s Quality Systems and with standard operating procedures (SOPs) that are consistent with regulatory requirements and industry standards.

Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.

Perform other related duties as assigned

Minimum Qualifications:

Bachelor degree in Nursing or Health Science; RN or LVN; five years relevant experience in clinical setting or equivalent combination of education and/or experience.

Working knowledge of relevant medical conditions and terminologies.

Must possess and demonstrate a strong customer-oriented attitude. Exhibits judgment and understanding of the issues; able to use reason even when dealing with emotional situations.

Ability to follow-through multiple projects simultaneously and set priorities with foreseeable time constraints.

Excellent interpersonal, oral and written communication skills

Must be proficient with MS Office, including Word and Excel.

Additional Requirements:

Working knowledge of technologies and treatment modalities in the field of aesthetic medicine.

Experience in aesthetic practice setting strongly preferred.

Experience in handling complaints in a FDA-regulated environment and experience in MDR reporting highly desirable.

Physical Demands and Work Environment:

While performing the duties of this job, the employee is regularly required to sit. The employee will be required to use a computer for up to 8 hours consecutively. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or control and talk or hear. The employee is occasionally required to reach with hands and arms and be mobile. The employee may be required to lift up to 15 lbs.

Specific vision abilities required by this job include close vision and color vision.

The noise level in the work environment is usually moderate.

Location:	Pleasanton, CA United States