Complaints Specialist Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a   Complaints Specialist  with our client, a leader in the medical device industry, located in Bridgewater, New Jersey. Primary responsibility is to support the reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with all applicable local laws and regulations. Assist in the management of information regarding Post Market Surveillance activities as directed. Initial assignment will be the EU-MDR implementation project., including assessment for pre and post-marketing medical device complaint management activities including:Receives, documents and evaluates information Evaluates and engages appropriate management for critical and/or unusual events. •Liaises with internal functions Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D to gather critical input data into medical device event PMS reports and/or Standard Operating procedures. Compiles process metrics and reports. Assists local affiliates with the preparation and submission of PMS Reports or data when required.Coordinates and prepares responses to competent authority govnquirys associated with medical device report submission. Serious Injury and/or Device Malfunction . Participate in preparation for Notified Body audits and or Competent Authority inspections. When required, supports root cause investigations and participates in CAPA Corrective and Preventive Action activities. Supports complaint handling trending activities.Generates complaint data reports for other departments, when requested. As required, supports department projects and/or participates in cross functional projects. Generates periodic reports as requested per government agencies and/or Notified Bodies. Requirements: Bachelor‘s degree in scientific or business related discipline required (Biomedical, Engineering, Science, etc.). Position requires strong written, oral and listening communication skills Must be able to generate and organize clear, concise responses when communicating with various levels of management. Superior organizational skills to be able to manage challenging deadlines.  Adjusts to change with minimum or no interruption.  Recognizes problems and suggests applicable solutions. Able to perform job function with minor supervision and make independent decisions, where appropriate.  Minimum of 3 years related work experience is required. Proficient in the use of personal computers, including database management, trending and word processing. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States. Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies 
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire* Apply Today!   •Available for purchase and administered by a designated third-party vendor  

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