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 company products 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.
Responsibilities include the following but not limited to:
• 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.
...0 AM Qualifications & Experience What you'll need: 1 year of delivery driving experience preferred Must have Forklift experience Valid driver's license Ability to pass a drug screen No DUI/DWI convictions that are less than...
Position And Perks Do you have a taste for great food and an eye for amazing presentation? Do you take pride in knowing that every guest is delighted by the food you have expertly prepared? Show off your skills in the kitchen and bring us your culinary talent! Join...
Job Description Job Description Job DescriptionPrimary Function The Senior Project Manager is responsible for the overall direction, coordination, completion, and financial outcome of constructionmanagement projects throughout their life cycle. This role includes mentoring...
...SharePoint Developer Location: Houston, TX 77010 Duration: 10 Months Day-to-Day Responsibilities/Workload: Microsoft SharePoint application and maintenance. Execution of on-premise SharePoint to SPO migration using any of the migration tools in the market...
Job Description Job Description Your job is to create an exceptional dining experience and develop moments for the guest to cherish and take with them! Build a friendship and a bond through the unmatched service! Welcome and Thank every Guest. Know your food, keep ...