Quality/Regulatory/Clinical

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.

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Quality Affairs Specialist

The Quality Affairs Specialist is responsible for the support and continuous improvement of the Wenzel Spine and IsoStem Quality Systems. In addition, the Quality Affairs Specialist will support supplier management, operations, and product development projects. The Quality Affairs Specialist reports to the COO.

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