Fresenius Medical Care North America (FMCNA) is a vertically integrated company that operates
the nation's largest network of dialysis clinics, is a leading manufacturer of dialysis
products, and provides laboratory services. With over 27,000 employees and 1061 clinics across
the country, our mission is to provide quality renal care to our 75,000+ patients.
The professional Services Speciaist will reviews and evaluates complaints against FMCNA
manufactured products. Determines if an event is reportable to federal regulatory agencies,
per Food and Drug Administration (FDA) and International Organization for Standardization
(ISO) reporting requirements and Standard Operating Procedures and takes appropriate action.
Documents and tracks reported product problems for FMCNA manufactured and distributed products
as required by the FDA and company procedures. Identifies trends and makes recommendations to
management. Provides regulatory guidance to manufacturing plants and clinics.
Qualified candidate will have a Bachelor's Degree in Science or Healthcare field or equivalent
relevant experience. RN degree preferred. Minimum of 4 years experience in the Healthcare
Industry (Nephrology) communicating with Doctors and Nurses. Previous experience processing
product complaints in the Medical Device Industry. Knowledge of FDA and ISO post-marketing
requirements for adverse event reporting required. Strong verbal and written communication
skills. Good people skills. Strong PC based computer skills, particularly data management
based systems such as MS Access and Excel.
Our corporate office is conveniently located near the intersection of Route 2 and Route 128 in
Lexington, MA. Fresenius offers such amenities as covered parking, on site cafeteria, fitness
room, dry cleaning service, and an active employee activities committee that contributes to
our rich corporate culture through participation in local sports leagues and charity events.
In addition, we offer a generous benefit package that includes medical and dental, 401k, short
and long term disability, tuition reimbursement, and a paid time off program. Fresenius Medical
Care is an Equal Opportunity Employer. For more information please visit our website at