Position Overview

Responsible for assisting in preparing strategy for worldwide product approval submission activities, submission activities focused on US/EU/Canada, and ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:
  • As a contributing member on product development and operations project teams, at times act as sole representative from Regulatory to ensure regulatory compliance.
  • Depending on product/project complexity, develop or assist in developing regulatory strategy and plans for assigned projects.
  • Execute the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
  • Write multiple technical sections of the regulatory submission or complete submissions.
  • Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  • Document, consolidate, and maintain verbal and written communication with regulatory agencies.
  • Maintain regulatory files and records.
  • Review change order documents and ascertains impact on current regulatory approvals.
  • Oversee the technical publishing of submissions and maintain regulatory files and records.
  • Build team cohesiveness by influencing and supporting team members.
  • Perform additional responsibilities as assigned.

    1. Minimum BA/BS degree or higher.
    2. Four (4) to six (6) years of professional regulatory experience.
    3. Strong technical writing skills as evidence by multiple 510k submissions, Technical Documentation applications, and/or clinical study protocols/reports.
    4. Experience interfacing with regulatory authorities through all stages of device life cycle.
    5. Strong written and verbal communication skills.
    6. Proficient computer skills (e.g., MS Office).
    Desired Qualifications
    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. Experience in leading small to medium sized teams.
    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.