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Director Regulatory Affairs Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2364479 |
| Location: San Jose, California |
Date Posted: 7/12/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: 6344259 |
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Job Description:
Business Unit, the BDB Discovery Labware Business Unit (DL), and serves as a member of the BDX WW Regulatory Leadership Team (RLT). This individual directs the regulatory affairs activities within BDB-CA and BDB-DL, which includes interactions between BDB and agents of the US FDA and health ministries outside of the US as required. He/she contributes to the development of BDB-CA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development. The Director will ensure functional excellence in regulatory activities to achieve rapid worldwide clearance/approval/registration/licensure of BDB products with desired claims. Additionally, this individual plays an active role in external efforts to develop policies, guidance, and standards of strategic importance to BDB. Requirements A minimum of a Bachelor\'s degree in a Life Science field A minimum of 7 yrs experience in regulatory affairs A minimum of 2 years supervisory or management experience. RAC (Regulatory Affairs Certification) Individuals with prior regulatory affairs work experience in a health care, pharmaceutical or medical device company highly desired. Experience with IVD products and FDA's OIVD, in either flow cytometry, immunoassay, or hematology would be ideal. Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
For more information, please click here to visit us at PharmaceuticalCrossing
For further information, please visit us online at http://www.pharmaceuticalcrossing.com
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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: PharmaceuticalCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.pharmaceuticalcrossing.com
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