Position Overview

INNOVATION STARTS WITH YOU
Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.

The Project Manager, Regulatory Affairsis responsible for obtaining regulatory approvals and ensures compliance with FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job Duties:
  • Serves as a member on project teams.
  • Identifies regulatory requirements in each country.
  • Develops worldwide regulatory strategies.
  • Prepares, reviews and files worldwide regulatory submissions and dossiers to ensure MicroVention devices are commercially available in the U.S. and international markets based on the organization’s objectives.
  • Communicates with regulatory agencies on administrative and routine matters.
  • Document, consolidate, and maintain oral and written communication with regulatory agencies.
  • Develops and maintains regulatory files and records.
  • Reviews change order documents and ascertain the impact on current regulatory approvals.
  • Reviews promotional material and labeling for regulatory compliance.
  • Required Qualifications
    1. B.S./B.A. degree in Science, Engineering or Medical Technology (orequivalent related experience)
    2. Medical device industry experience (minimum five to seven years preferred)
    3. Regulatory Affairs experience (minimum five to seven years preferred)
    4. Extensive experience in preparation of U.S. and international regulatory submissions including 510(k), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Pre-Market Approval (PMA) and Design
    5. Excellent leadership skills
    6. Ability to work well in a team environment
    7. Detail oriented
    8. Proven analytical abilities and organization skills
    9. Ability to comprehend technical documents and concepts
    10. Proficient computer skills (e.g., MS Office)