Complaint Analyst - Fully Remote
Location : Clifton NJ US 07013
Job Type : Temp/Contract
Reference Code : 20849-BZ1
Compensation : open - 25-28/h
Start Date : 01/13/2022
Hours : Full Time
Required Years of Experience : 3
Required Education : High School Diploma / GED
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Contract position for a Complaints Analyst for medical device manufacturing.
- Work in a team environment with members of the Engineering and Medical teams on completion of Decision Tree (DT) and completion / submission of Initial MDRs.
- Work independently and with different parts of the organization/departments to perform Good Faith Effort (GFE) to obtain required / additional event information and request sample return.
- Ensure complaints are handled in compliance with applicable regulations and regulatory standards.
- Accountable for compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) regulations governing adverse event reports such as Medical Device Reports (MDR) and Medical Device Vigilance (MDV) and reportability requirements for various countries.
Required Qualifications :
- High School degree or equivalent required. A Bachelor’s degree in a Science or related technical field is preferred.
- Knowledge of working with quality systems per 21 CFR 820, 21 CFR 803, ISO 13485 is preferred.
- Knowledge in record keeping, computer software, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred.
- Ability to communicate clearly and concisely (written and oral), including technical writing skills.
- Proficiency with Microsoft Office Word, Excel, Visio, Power Point, or equivalent software applications is required.
- Ability to analyze information objectively and make a reasoned judgment.
- Ability to analyze data and determine if there is a problem.
Contact: Bill Zukowsky