Manager, Regulatory Affairs

Best Places to Work 2021

Position Overview

This position is responsible for generating regulatory strategies to commercialize or conduct clinical investigations of MicroVention products. These activities will primarily focus on the United States, European Union, Canada, and support Rest of the World (ROW) markets:
  • Supervises, mentors, and provides leadership to the regulatory affairs support staff; hires and trains new associates. Manages resource allocation and provides career development and job performance feedback.
  • Excellent knowledge of U.S., European and International regulations, including EU MDR.
  • Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other strategic matters.
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines.
  • 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 regulatory submissions to ensure MicroVention devices are commercially available globally based on the organization’s objectives.
  • Reviews change order documents to validate staff assessments, as applicable.
  • Reviews promotional material and product labeling for regulatory compliance, as applicable.
  • Develops and maintains regulatory files and records.
  • Supports training for global regulatory processes and system implementations.
  • Builds team cohesiveness by influencing, coaching, and mentoring team members.
  • Performs additional responsibilities as assigned.

Job Details

    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. Demonstrated experience in preparation of U.S. and European regulatory submissions
    4. Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
    5. Experience in leading moderate sized project teams.
    6. Ability to comprehend technical documents and concepts.
    7. Proficient computer skills (e.g., MS Office).
    Desired Qualifications
    1. Detail oriented.
    2. Supervisory experience.
    3. Experience in leading project teams.\\\\
    4. Abilityto work well in a team environment.
    5. Proven analytical abilities and organization skills.
    6. Demonstrated 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 Technical Documentation applications (implant and catheter experience preferred).