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Director of Regulatory Affairs and Quality Control

Director of Regulatory Affairs and Quality Control

Position Filled
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Salt Lake City
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Director of Regulatory and Quality
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$180K - $200K Base plus bonus and equity participation
Application Deadline Date
Salary Type
Base plus Bonus
Experience Level
• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred). • 10+ years of progressive experience in Regulatory Affairs and Quality within medical devices or biomaterials. • Direct experience with FDA submissions (510(k), De Novo, IDE, PMA). • Strong working knowledge of QSR, ISO 13485, and risk management standards. • Experience supporting manufacturing, supplier quality, and audits.
Compensation Type
Salary plus Commissions

Seeking an experienced Director of Regulatory Affairs & Quality Control to lead global regulatory strategy and quality system execution across its expanding silicon nitride (SiN) and SiN/PEEK biomaterial platforms. This role will be critical in supporting3D-printed patient-specific implants, antipathogenic wound-management and soft-tissue technologies, and the commercial launch and lifecycle management of the SINERGY™ SiN/PEEK biomaterial.

 

The successful candidate will provide hands-on leadership across FDA regulatory submissions, quality system compliance, partner enablement, and post-market surveillance, while helping position SINTX as a best-in-class biomaterials platform company capable of supporting both internal products and external licensing opportunities.

screspi@harrismedicalconsultants.com or contact direct at 303-818-2202

Stuart Crespi
Executive Search Consultant
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