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Abbott
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Santa Clara, California
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provide clinical knowledge, expertise and direction relevant to manufacturing, quality, performance and ... affairs).
Write device Instructions For Use (IFU).
Participate in the Risk Analysis process for
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Abbott
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Santa Clara, California
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review process to ensure submission approval
Ensure compliance with US and global product post marketing approval requirements
Evaluate proposed preclinical, clinical and manufacturing changes for
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Abbott
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Santa Clara, California
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subject matter expert for guidelines and regulations regarding the clinical evaluation process and its
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Abbott
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Santa Clara, California
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authorities.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Negotiate and interact with regulatory authorities during the development and review process
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