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Jan S

Regulatory Compliance Analyst

Occupation:

Quality Coordinator

Location:

Avoca, NY

Education Level:

High School/GED

Will Relocate:

No

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Highly proactive, Compliance for US Medical Devices review of product labels, literature and catalog copy.

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COMPANY POSITION HELD DATES WORKED

(Confidential) (Confidential) 12/1980 - Present
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SCHOOL MAJOR YEAR DEGREE

Niles West General 1975 High School/GED Degree
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Highlights:

Through the review process in 17+ years there have been no product actions required due to labeling. My personal process and policies were benchmarked by a major medical device company

Companies I like:

Fenwal, Hollister, Baxter, Hospira

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CollapseResponsibilities

. Proven ability to create, implement, and administrate a qualified documentation process to assist in regulatory compliance for a diverse product line consisting of over 7,000 products and including medical devices, OTC drug products including drug facts, laboratory and IVD product lines. Responsible for the development, implementation and management of a compliance program designed to meet the needs of state regulated mercury containing products, including thru the utilization of DreamWeaver, the web site creation as a management tool, systems and processes to assure compliance.
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