Project Manager, Regulatory Affairs (RA)

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:
  • Develops and executes the regulatory plan.
  • Represents Regulatory on product development and process/systems improvement project teams and partners with cross functional team members.
  • Identifies regulatory requirements for the markets identified in the regulatory strategy.
  • Writes, reviews and files regulatory submissions and dossiers to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  • 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 and approves promotional material and labeling for regulatory compliance.
  • Develops and maintains regulatory processes and leads department process improvements.
  • Supports and contributes into developing, editing or revising 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.

Job Details

    1. Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    2. Five (5) to eight (8) years of professional regulatory experience.
    3. Documented experience in preparation of U.S. submissions and Design Dossier application.
    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 Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications submission.
    2. Experience in leading project 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.
    7. Proficient computer skills (e.g., MS Office).