Primarily responsible for writing, reviewing and submitting regulatory reports for the complaint handling process. Additionally, responsible for supporting complaint handling investigations with summarizing the clinical event that occurred by assessing details of the event for complaint investigation and reporting. Partners with other departments, facilities, and clinical professionals from a technical and functional perspective. Responds to questions and liaises with fellow department staff members regarding complaint data entry and processing.
- Provides guidance to fellow staff members related to the clinical use and information related to the reported event.
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
- Applies knowledge of global regulatory device requirements in order to support clinical decisions for reporting within regulatory time frames.
- Responsible for the reviewing of MDR/Vigilance decision trees and is able to review and complete MDR/Vigilance submissions.
- Interfaces with Quality Engineering and other departments for product investigations and trend reporting.
- Assists in the closure of assigned complaint files in a consistent and timely manner, and ensures that all pertinent information is contained within the file prior to closure. Monitors and reports on complaint metrics as required.
- Responsible for receiving, reviewing, entering, and communicating event reporting and investigation results through regulatory reports and written communications.
- Assists with request to customers and provides preliminary support as required.
- Assists with various projects as assigned by direct supervisor.
- Must be able to proactively prioritize workload
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- Bachelors degree in nursing required; masters degree preferred
- Active Registered Nurse license required
- 5-8 years of applicable clinical experience required
- 3-5 years medical device experience preferred (complaint handling and MDR/Vigilance)
- Requires occasional early morning or evening teleconferences.
- Must be willing and able to travel as needed.
- Works under general office environmental conditions.
- Sits for extended periods, utilizes close visual acuity for working with computers, etc.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.