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Senior Regulatory Affairs SpecialistLumenis - Salt Lake City, UTResponsible for the coordination and preparation of document packages for US and international regulatory submissions from all areas of company, internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of submissions and of clinical trial applications. Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables. Exercises independent judgement...originally from Lumenis Ltd. - More Tools...
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