Required a Bachelors degree, or foreign degree equivalent, in Biomedical Engineering, or related field. Must have 5 years of experience in the job offered or related position. Must have 5 years of experience in the following Working with internal and external stakeholders in the medical device or pharmaceutical fields; working with US FDA and European EU medical device regulatory requirements including regulations, guidance, and standards; and hands on experience with medical device dossiers, submissions, audits and interactions with Health Authorities, such as US FDA Class II and Class III submissions andor international submissions.

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