Regulatory Specialist/Manager

The Regulatory Manager is responsible for overseeing the regulatory process for Wenzel Spine and IsoStem products requiring governmental approval, including filing necessary applications and handling all regulatory authority interactions. In addition, the Regulatory Manager works with the Quality Manager to coordinate and support inspections of the organization and the development of procedures to ensure regulatory compliance. The Regulatory Manager reports to the Director of Regulatory Compliance and Clinical Research.

Job Type:

Full Time

Location:

Austin

Job Functions:

  • Support/Manage all Regulatory Affairs for Wenzel Spine, Inc. & IsoStem, Inc.
  • Develop and support/manage implementation of strategic plan for Product Development regulatory activities.
  • Support/Manage product submissions for US product clearance and International product registrations.
  • Monitor external regulatory developments and communicate changes and potential issues to senior management.
  • Manage the Standards Library, including continuous monitoring of new revisions, amendments, etc.
  • Support/Manage implementation of Unique Device Identification (UDI) regulations for all products.
  • Assist/Manage development and continuous updates for product Technical Files.
  • Assist/Manage communications with Authorized Rep for European product distribution.
  • Support/Manage communication with Notified Body and Regulatory Authorities.
  • Support Quality audits/inspections by Notified Body and Regulatory Authority.
  • Develop Regulatory procedures and records to ensure regulatory compliance.
  • Required Qualifications:

    • Minimum of 3 years of experience managing US and/or International Medical Device Regulatory Affairs. Spinal device experience preferred.
    • Minimum of 3 years of experience working in an ISO 13485 and FDA compliant quality system, orthopedics or spine medical device preferred.
    • Strong computer skills, to include: Outlook, Excel, Power Point, Visio, and Word.
    • Strong work ethic, highly motivated self-starter, with excellent presentation and communication skills.
    • Ability to work on multiple projects and support multiple disciplines at any given time.

    Experience:

    3-5+ Years

    Education:

    4-year College Degree. BS preferred.

    License/Certification:

    RAC preferred but no required.

    Travel Required:

    yes