Food And Drug Regulatory Director Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2345302
Location: Waltham, Massachusetts	Date Posted: 7/5/2008
Wage:	Category: Medical/Health
Job Code:

Job Description:
Develops policies, provides training, audits, and provides other compliance assistance in these areas of responsibility. Serves as senior specialist in these areas, mentoring and coordinating those specialists in these areas assigned to affected businesses, to include leading company FDA network among those businesses. Serves as Official Correspondent for Thermo Fisher with US FDA. Comments on and influences regulatory developments in these area. Minimum Requirements/Qualifications: Undergraduate degree in technical specialty (e.g. engineering, chemistry, or biology) required.Graduate education in similar field or law desired.Minimum ten years U.S. industrial or government experience with food and drug laws particularly those relating to medical devices/biotechnology including in vitro diagnostic devices required. Hands-on experience with classification of devices: listing, registration, and approval of devices; adverse event reporting, corrective and remedial actions and recalls required. Knowledge of the requirements of current Good Manufacturing Practice (GMP), FDA Quality Systems Regulation and ISO quality assurance required.Experience with similar ex US (e.g. Canada, China, EU, Japan) food and drug laws strongly desired.Experience with EU IVD, Food Chemical Codex, US Pharmacopoeia

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Job Criteria:
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Position Type: Full-Time Permanent
Years of Experience Required:
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Contact Name: -	Company Type: Employer
Company: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.pharmaceuticalcrossing.com