Director, Regulatory Affairs Job

Employer Name: BiotechCrossing	SpiderID: 2388310
Location: Framingham, Massachusetts	Date Posted: 7/23/2008
Wage:	Category: Biotech
Job Code: 6525710

Job Description:
FORTUNE magazine as one of the 100 Best Companies to Work For in 2007 in the United States?. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success. Job Title: Director, Regulatory Affairs, Diagnostics Job Responsibilities/Department description: The Director, Regulatory Affairs, Diagnostics, will assure that global regulatory requirements are met through the product life cycle, from submissions to post-market compliance. The director leads a highly motivated regulatory team to support aggressive product development plans and will lead and delegate any interactions with FDA and other regulatory authorities for current and future product offerings. (Current products include formulated reagents and lateral flow ?rapid? tests.) The successful candidate is expected to be expert in the requirements of Design Controls and preparation of documentation for market clearances in the United States, Europe and other emerging markets, as necessary. The director will provide leadership for influencing regulations and standards that affect the Division?s business objectives and the diagnostics industry. He/She will also be a key liaison with marketing partners who rely on innovative regulatory approaches for enabling market entry worldwide.

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Job Criteria:
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Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
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Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
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Web Site: http://www.biotechcrossing.com