Medline Industries has an opportunity available for a Clinical Product Surveillance Specialist with our Quality Division. Position is based in the Northfield, IL headquarters. Individual will act as a liaison between customers, sales reps and the product division serving as a clinical resource and provide direction as needed for clinical issues. In addition will provide guidance to a cross-functional team on clinical scenarios and how to identify potentially hazardous situations in complaints. Opportunity to use knowledge of clinical workflow and product use in assessing incoming complaints and the hazards they may contain as well as assisting in determining post-market reportability. Will also play an active role when clinical investigations are needed for reported product incidents and submit adverse event reports as required. We are seeking a dynamic, hard-working professional with a desire to work for a fast-paced, large corporate organization with “roll-up your sleeves” attitude.
Evaluate complaints from patient safety perspective and identify complaints that require further evaluation.
Work independently to prepare and submit Medical Device Reports (MDRs) to the FDA.
Processes MDR’s as required; notify the appropriate international representatives when reports must be filed with their local health authorities.
Ensure reportable complaints are processed and submitted accurately and on time. Collaborate with team members; act as a clinical resource to QA and product division.
Use discretion and independent clinically-based judgment to: review, evaluate and classify potential reportable complaints.
Ensure customer communications are created and issued; review customer responses for technical accuracy related to Medline products.
Participate in risk analysis activities for new and existing products; provide clinical insight and review.
Analyze data on patient safety and risk, ensuring compliance with applicable post-market regulations
Manage risk by identifying product safety issues; triage complaints for further investigation
Bachelor’s degree in medical science, heath sciences or healthcare related field. Nursing preferred.
Will be considered: high school diploma/equivalency degree plus a minimum of 6 years of clinical experience.
Licensed, registered, or certified by a state or other governing body to administer health care.
At least 2 years of clinical experience (e.g. critical care, med/surg, home health). Operating Room
experience with a thorough understanding of the operating room environment
Experience applying knowledge of FDA and international Health Authority reporting requirements preferred.
Understanding of the clinical environment and product work flow.
Familiarity with the application of medical device as it relates to patient safety preferred.
Experience with analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Experience communicating technical information to non-technical audiences.
Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.
Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary.
Prior experience working with Microsoft Office products.