Regulatory Affairs Specialist

The Regulatory Specialist is responsible for supporting the regulatory process for Wenzel Spine and IsoStem products requiring governmental approval, including filing necessary applications and participating in all regulatory authority interactions. In addition, the Regulatory Specialist works with the Quality Affairs Specialist to coordinate and support inspections of the organization and the development of procedures to ensure regulatory compliance. The Regulatory Specialist reports to the COO.

Job Type:

Full Time

Location:

Austin

Job Functions:

  • All Regulatory Affairs for Wenzel Spine, Inc. & IsoStem, Inc., including writing procedures, and record management.
  • Implementation of strategic plan for Product Development regulatory activities.
  • Product submissions for US product clearance (510k) and International product registrations.
  • External regulatory developments / changes and effective communication to management.
  • Standards Library, including continuous monitoring of new revisions, amendments, etc.
  • Maintenance of Unique Device Identification (UDI) regulations for all products.
  • Development and continuous updates for product EU Technical Files or Design Dossiers.
  • Communication with Authorized Rep for European product distribution.
  • Communication with Notified Body and Regulatory Authorities.
  • Quality audits/inspections by Notified Body and Regulatory Authority.
  • Required Qualifications:

    • Minimum of 2 years of experience managing US and/or International Medical Device Regulatory Affairs. Spinal device experience preferred.
    • Minimum of 2 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:

    2+ Years

    Education:

    High School Diploma, 4-year College Degree (BS) preferred.

    License/Certification:

    RAC preferred but no required.

    Travel Required:

    yes