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

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	(Confidential)	12/1980 - Present

SCHOOL	MAJOR	YEAR	DEGREE
Niles West	General	1975	High School/GED Degree

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

• Regulatory
• Labeling
• Quality

. 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.