Position Overview

This position is responsible for leading process improvement efforts across the Regulatory Affairs department by supporting submissions, developing, implementing, and maintaining systems. Job duties:
  • Serve on business and department projects for process/system updates and implementations.
  • Responsible for regulatory activities, training others, developing and implementing plans, and providing input to system requirements.
  • Ensure compliance to regulations pertaining to site establishment registrations, certificates, and licensing.
  • Maintain regulatory files and records.
  • Technical publishing of submissions.
  • Support established regulatory procedures and establish processes and procedures as needed, initiating updates as necessary in a regulated environment.
  • Build team cohesiveness by influencing and supporting team members.
  • Performs additional duties as assigned.

    • Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.
    • One (1) to two (2) years of professional regulatory experience.
    • Excellent written and verbal communication skills.
    Desired Qualifications
    • Ability to work well in a team environment.
    • Proven analytical, organizational, and project management skills. Able to efficiently manage multiple projects and priorities.
    • Proficient computer skills (e.g., MS Office, Sharepoint, Adobe Acrobat, SAP).
    • Experience with Windchill PLM or other document management systems used in the medical device industry.
    • Experience with UDI coordination and EU MDR preferred.
    • Ability to quickly learn new computer technology software packages