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US-Nationwide, Permanent position as Biologics or Medical Device Quality Systems Consultant (Biotech |
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Job Category:
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Bioinformatics |
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Job description:
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This is a permanent position with a consulting company and will function as a senior level consultant on quality systems issues for biologics and/or medical device clients.
For this role you must have a thorough background in quality assurance and you must have worked for the FDA (or a foreign regulatory body) as either a member of the Team Biologics group or as a Medical Device expert.
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Skills:
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At least 10 years experience with the implementation and/or auditing of either: FDA’s medical device Quality System Regulation, 21 CFR 820 and Medical Device Reporting regulation, 21 CFR 803, or the design, implementation and/or auditing of quality systems and regulatory compliance for the manufacture of biologic drug products (blood products for transfusion, or biotechnology-derived products such as recombinant technology, monoclonal antibodies, etc, or vaccines)
Bachelor’s degree, advanced degree preferred
Regulatory agency experience should be with the Food and Drug Administration or similar agency at the State level in the United States, or a comparable agency in another country (such as Health Canada, the British MHRA, or equivalent agency)
Demonstrable knowledge of FDA methods and practices for conducting inspections, including specifically pre-approval inspections
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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10 |
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Job Location:
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Austin - TX - USA |
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Post Date:
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11/17/2008 |
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