This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:
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Serves as a member on project teams completing tasks as assigned by the team.
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Aides in the execution of the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
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Assists in preparing regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
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Aides in integrating various sources of information into a uniform style and language for regulatory submissions.
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Documents, consolidates and maintains verbal and written communication with regulatory agencies.
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Maintains regulatory files and records.
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Assists in reviewing change order documents and ascertains impact on current regulatory approvals.
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Assists with technical publishing of submissions.
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Supports and contributes into editing/revising Standard Operating Procedures.
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Builds team cohesiveness by supporting team members.
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Performs other duties and responsibilities as assigned.