Manager, Product Monitoring: FPC of Mt. Baker
| Company Name | FPC of Mt. Baker |
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| Job Category | Pharmaceutical/Biotech |
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| Location | St. Louis, MO |
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| Position Type | Full-Time, Employee |
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| Salary | $80,000 to $100,000 per year |
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| Experience | 5-10 Years Experience |
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| Desired Education Level | Bachelor of Science |
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| Date Posted | May 7, 2008 |
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| View FPC of Mt. Baker profile and job listings |
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| Title |
Manager, Product Monitoring |
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| Description |
Position Summary:
Manage the day to day processes and analysts responsible for handling complaints of medical devices. Ensuring compliance with FDA regulations, FDA guidances and corporate procedures for complaint handling, MDR reporting and the providing of medical information by Product Monitoring (CPM). Develop, maintain and continually improve formats for organizing and publishing feedback from the field in ways which are relevant and useful to internal customers and corporate and site quality departments. Establish and maintain positive and mutally rewarding relationships with external and internal customers.
Essential Function:
Responsible for the day to day functioning of PM relative to medical device product complaint handling and the providing of medical information for medical devices.
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| Requirements |
QUALIFICATIONS:
Education:
Bachelor's degree in clinical field or other college degree with relevant experience.
Experience:
A minimum of 5 years in the medical device industry preferably in a quality or regulatory role. Thorough knowledge of FDA complaint & MDR reporting regulations strongly preferred. Knowldegeof international regulations for complaint and vigilance reproting strongly preferred.
Preferred Skills:
-Previous managerial experience
-Knowledge of products which Product Monitoring supports and their use in the field (-Experience in the evaluation of medical literature and other scientific reports
-Excellent verbal and written communication skills.
-Experience in computer applications such as Microsoft Word, Excel, Access and Power Point. | |
