15 days old

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.

Day shift - 40 hours a week until the end of the year- Likely to extend

**Responsibilitie** s

+ 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.

+ 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.

**Qualifications Associate or BS degree and related** **experience**

**What happens next**

Once you apply, youll proceed to the next steps if your skills and experience look like a good fit. But dont worryeven if this position doesnt work out, youre still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover **whats next** in your career is what were all about,


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-09-19 Expires: 2022-10-20

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Complaint Specialist

Kelly Services
Rochester, NY 14651

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