Position Overview

This position is responsible for obtaining regulatory approvals and ensures compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Job duties:
  • Serves as a senior Regulatory representative on project teams.
  • Develops and executes worldwide regulatory strategies and plans.
  • Represents Regulatory on teams and partners with team leaders to ensure alignment of regulatory strategy and plans with the team objectives.
  • Writes, 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.
  • Documents, consolidates and maintains verbal and written communication with the regulatory agencies.
  • Reviews change order documents and ascertains impact on current regulatory approvals.
  • Reviews promotional material and labeling for regulatory compliance.
  • Develops and maintains regulatory files and records.
  • Develops, edits or revises regulatory processes.
  • Supports training for global regulatory processes and system implementations.
  • Builds team cohesiveness by influencing and mentoring team members.
  • Performs other duties and responsibilities as assigned.

    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. Seven (7) to ten (10) years of professional regulatory experience.
    3. Documented 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 Dossier applications (implant and catheter experience preferred).
    4. Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
    5. Experience in leading moderate sized teams.
    Desired Qualifications
    1. Experience in leading project 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).