Specialist, Regulatory Affairs

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:

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