Go back out to the field for further information on complaints
File regulatory reports
Education Required: Bachelor's degree required
Years' Experience Required: 0+ years of experience
Position Summary:
In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for client's Surgical Devices to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.
Duties:
Apply policies and procedures to comply with FDA and OUS regulations.
Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
Maintain awareness of new products, government regulations and requirements.
Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
Must Have experience:
Bachelor degree
High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc)
0-2 years experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
Nice to Have
Degree in Health Care, Sciences, or Bio-Medical Engineering