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1+ months

Complaint Specialist

Kelly Services
Rochester, NY 14651
Complaint Specialist


Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a long term contract opportunity for a Complaint Specialist with our client, a leader in the Medical Device industry, located in Rochester, NY.


Primary responsibility is to support the global 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 applicable local laws and regulations.


KEY ACTIVITIES/RESPONSIBILITIES Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities including:


+ Receives, documents and evaluates complaint information. As required, communicates with physician, physician s staff and/or patient to obtain pertinent complaint 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 into medical device event reports.

+ Reviews complaint manufacturing investigation reports and provides comments in accordance with procedures.

+ Performs and/or documents regulatory reportability decisions on complaints in accordance with applicable local laws regulations.

+ Ensures complaints are processed in a timely manner.

+ Reviews and closes complaint files.

+ Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations.

+ Codes complaints and adverse events using IMDRF adverse event terminologies terms and codes .

+ Assists local affiliates with the preparation and submission of medical device complaints and or incident reports, when required.

+ Coordinates and prepares responses to competent authority inquiry s 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, support root cause investigations and participates in CAPA Corrective and Preventive Action activities.

+ Compiles case and process metrics. 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.


SCOPE OF POSITION The scope of this position is directly related to global complaint management and adverse event reporting responsibilities for all company medical device products as assigned. The position will include interaction and communication with doctors and patients as well as internal business stakeholders.


**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** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-07-05 Expires: 2021-10-16

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Complaint Specialist

Kelly Services
Rochester, NY 14651

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