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1+ months

Surveillance Analyst

Kelly Services
Schaumburg, IL 60173
**Kelly Science has an immediate opening for our growing client in Schaumburg, IL for a Surveillance Analyst**


**Salary: $80,000/year**


As a Surveillance Analyst, you will be responsible for the customer complaint process, from entering the customer complaints into the company-wide complaint system, determining additional actions required based on the nature of the complaint, and following those actions to completion, including reporting to regulatory authorities. Additionally, you will be responsible for the complaint/vigilance data analysis and subsequent generation of Surveillance Analyst reports for products. You will be responsible for suggesting and implementing improvements to the overall complaint handling process to increase accuracy and efficiencies in the system.


**Responsibilities**


+ Review complaints and determine reportability to FDA and international regulatory authorities

+ Write, review, and file Medical Device Reports (MDRs)

+ Write, review, and file Vigilance Reports

+ Works closely with Sales Representatives and health care professionals to obtain additional information

+ Monitor quality, completeness and timeliness of complaint investigations

+ Write customer response letters

+ Write periodic Post Market Surveillance reports, per internal procedures

+ Interface with contract manufacturers and suppliers to facilitate investigations

+ Identify and implement opportunities for improvement to the Feedback/Complaint system

+ Trend and analyze complaint data.

+ Contribute to achieving team performance metrics and goals

+ Represent Quality function as a member on team projects to complete assignments or delegate assignments

+ Collaborate with other teams, customers, and regulatory agency representatives, to develop product solutions

+ Review team progress with management

+ Review external literature for potential adverse events related to products, or similar products

+ Other duties as assigned


**Requirements**



+ Bachelors degree in a technical or scientific discipline

+ 3 years of work experience in the Medical Device industry

+ Experience with FDA Medical Device Reporting and International Vigilance Reports required

+ In depth knowledge/certification on medical device regulations and guidelines

+ Detail oriented approach to work

+ Excellent Time management skills and prioritization are key

+ Excellent verbal and written communications


**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)
Posted: 2021-08-13 Expires: 2021-10-14

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Surveillance Analyst

Kelly Services
Schaumburg, IL 60173

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