Position Overview

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.

    1. Minimum BA/BS degree in a scientific or technical discipline or relevant field of study. Advanced degree may offset medical device industry experience.
    2. Minimum of three (3) years of Medical Device/Pharma industry experience.
    3. Must read/write Mandarin/English.
    Desired Qualifications
    1. Minimum one (1) year Regulatory Affairs Experience.
    2. Leadership skills.
    3. Ability to work well in a team environment.
    4. Detail oriented.
    5. Proven analytical abilities and organization skills.
    6. Ability to comprehend technical documents and concepts.
    7. Proficient computer skills (e.g., MS Office).