Project Manager, Regulatory Affairs

Position Overview

Responsible for preparing strategy for worldwide product approval submission activities, responsible for submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices. Job duties:
  • Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of regulatory strategy and plans with the team objectives.
  • Identify regulatory requirements for the markets identified in the regulatory strategy.
  • Develop and execute the regulatory strategy and plan for assigned projects.
  • Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  • Communicate with regulatory agencies on administrative and routine matters.
  • Document, consolidate, and maintain verbal and written communication with the regulatory agencies.
  • Review change order documents and ascertain impact on current regulatory approvals.
  • Review promotional material and labeling for regulatory compliance.
  • Develop and maintain regulatory files and records.
  • Support and contribute into developing, editing, or revising regulatory processes.
  • Support training for global regulatory processes and system implementations.
  • Build team cohesiveness by influencing and mentoring team members.
  • Perform additional responsibilities as assigned.


Job Details

    1. Minimum BA/BS degree or higher.
    2. Five (5) to eight (8) years of professional regulatory experience.
    3. Strong technical writing skills as evidence by multiple 510k submissions, PMA Supplements, Technical Documentation and/or clinical study protocols/reports.
    4. Experience interfacing with relevant regulatory authorities through all stages of device life cycle.
    5. Experience in leading moderate sized teams.
    6. Strong written and verbal communication skills.
    7. Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams.
    Desired Qualifications
    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. Experience in 510(k), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications submission.
    3. Experience in leading project teams.
    4. Ability to work well in a team environment.
    5. Detail oriented.
    6. Proven analytical abilities and organization skills.
    7. Ability to comprehend technical documents and concepts.
    Comply with applicable Laws and Regulations, adhere to Quality as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.