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 medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company 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.

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:
  1. Serves on product development and operations teams to ensure regulatory compliance.
  2. Executes the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
  3. Writes various technical sections of the regulatory submission.
  4. Prepares regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  5. Integrates various sources of information into a uniform style and language for regulatory submissions.
  6. Documents, consolidates and maintains verbal and written communication with regulatory agencies.
  7. Reviews change order documents and ascertains impact on current regulatory approvals.
  8. Reviews promotional material and labeling for regulatory compliance as assigned.
  9. Maintains regulatory files and records.
  10. Technical publishing of submissions.
  11. Edits/revises Standard Operating Procedures.
  12. Builds team cohesiveness by influencing and supporting team members.
  13. Performs other duties and responsibilities
  • Required Qualifications
    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. One (1) to four (4) years of professional regulatory experience.
    3. Experience in the preparation of U.S. 510(k) submissions, PMA submissions and/or Design Dossier applications.
    4. Experience interfacing with relevant regulatory authorities through various stages of device life cycle.
    Desired Qualifications
    1. Leading small teams.
    2. Ability to work well in a team environment.
    3. Detail oriented.
    4. Proven analytical abilities and organization skills.
    5. Ability to comprehend technical documents and concepts.
    6. Proficient computer skills (e.g., MS Office).


    Additional Information
    • The primary work location for this position is Aliso Viejo, CA (company headquarters)
    • Candidates must be eligible to work in the U.S. and not require visa sponsorship.

    Comments
    MicroVention® TERUMO was founded in 1997, employs approximately 2,800 worldwide, and has experienced double-digit revenue growth year-over-year 3 years running. Recognized as one of the “Top Workplaces” in Orange County, California, we have a thriving culture that is innovative, customer-focused, clinically driven, demonstrates a team spirit, and empowers its employees to challenge the status quo. “MicroVention® TERUMO…Innovation Starts with You”.