Director, Regulatory Affairs job Framingham Massachusetts
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Director, Regulatory Affairs Job
Employer Name: BiotechCrossing
SpiderID: 2385160
Location: Framingham, Massachusetts
Date Posted: 7/22/2008
Wage:
Category: Biotech
Job Code: 6525710
Job Description:
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. The director is a member of the Division?
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
Contact Name: -
Company Type: Employer
Company: BiotechCrossing
City: Pasadena
State: California
Zip:
Web Site:
http://www.biotechcrossing.com
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