Complaints Investigator (Life Sciences) 10/11/2017

HumanEdge Pompton Plains, NJ

Company
HumanEdge
Location
Pompton Plains, NJ
AJE Ref #
579731842
Job Classification
Full Time
Job Type
Regular
Company Ref #
375131
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

APPLY
p Complaints Investigator needed in the Pompton Plains, NJ area. Provides support and assistance in the evaluation of Product Complaints for Medical Device Report (MDR) and Vigilance (MDV) reports. Responsible for reporting of complaints, evaluation of returned products and processing of trending analysis, in accordance with Corporate, Site, and department procedures, and regulatory requirements. The Product Analyst Complaints will interact with medical professionals to support in the complaint investigations. /p p Our client is a global medical technology company that originated in the early 1900s. Their biggest commitment is to the mission of saving lives through the products they offer. /p ul li Ensure timely, accurate and complete failure investigations of product complaints leading to the root cause and corrective/preventive action. /li li Gathers and reports various complaints metrics. /li li Presents critical information at Complaint Reviews. /li li Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries. /li li Responsible for communicating business related issues or opportunities to next management level. /li li Investigates and processes product complaints while maintaining compliance with all regulations. /li li Investigation and documentation of field clinical events and follow-up with Sales Representatives. /li li 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. /li li Assisting with Product Field Actions as required. /li li Collecting follow up information related to complaints from customers. /li li Typically through the Sales and/or Field Service groups. /li /ul ul li Prior experience performing product evaluation in a regulated industry is preferred. /li li Knowledge in record keeping, computer software, laboratory procedures used for evaluation of samples, and procedures related to Complaint-Handling and MDR/vigilance reporting in accordance with all applicable regulations is preferred. /li li Prior experience with the products and their usage is highly desirable. /li li Must demonstrate effective written and verbal communication, including technical writing skills. /li li Experience with SAP is preferred. Proficiency with Microsoft Office Products such as Word, Excel and PowerPoint or equivalent software applications is preferred. /li li Familiarity with Catsweb software is preferred. /li /ul br