VP of Regulatory Affairs & Quality Assurance

Sintx Technologies Inc•Salt Lake City, UT

59d•$180,000 - $225,000

About The Position

SINTX Technologies is seeking an experienced VP of Regulatory Affairs & Quality Assurance 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 supporting 3D-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.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
10+ years of progressive experience in Regulatory Affairs and Quality within orthopedic medical devices or biomaterials.
Direct experience with FDA submissions & PMS (520b, 510(k), De Novo, IDE, PMA).
Strong working knowledge of QSR, ISO 13485, and risk management standards.
Experience supporting manufacturing, supplier quality, and audits.

Nice To Haves

Experience with additive manufacturing / 3D-printed medical devices
Experience with patient-specific and custom medical devices
Experience with biomaterials platforms or materials-science-driven technologies
Familiarity with antimicrobial or antipathogenic technologies
Familiarity with licensing or partner-driven commercialization models
Prior experience interacting directly with the FDA in Q-Subs and audits.
Experience with and advanced certification in Lean Six Sigma methodologies

Responsibilities

Develop and execute U.S. and international regulatory strategies for conventional and additively manufactured implants for traditional and patient-specific applications using SiN biomaterials (including 520b), silicon nitride–based wound management, suture, and soft-tissue applications, and biomaterial platforms intended for internal use and third-party licensing.
Lead and manage FDA submissions, including 520b, 510(k)s, De Novo requests, IDEs, PMAs (as applicable), and Q-Submissions.
Serve as the primary regulatory interface with the FDA and international regulatory bodies.
Evaluate regulatory risks and timelines for new indications and changes to materials, processes, and designs.
Own and continuously improve SINTX’s Quality Management System (QMS) in compliance with 21 CFR Part 820 (QSR), ISO 13485, ISO 14971 (Risk Management), and applicable ASTM and additive manufacturing standards.
Oversee design, process and document controls, supplier qualification and audits, CAPA, complaints, nonconformance, and change control, and internal and external audits (FDA, notified bodies, partners).
Ensure quality readiness to support scalable manufacturing, clinical use, and partner commercialization.
Provide regulatory and quality leadership for the launch and expansion of SINERGY™ SiN/PEEK biomaterial, including intended use expansion, new form factors, and manufacturing scale-up – process validation and risk mitigation.
Support post-market surveillance, vigilance reporting, and lifecycle regulatory maintenance.
Collaborate with R&D and manufacturing to ensure regulatory alignment during material innovation and process optimization.
Support implementation and maintenance of Lean Six Sigma methods for process control and waste minimization.
Enable regulatory and quality frameworks that support licensing, co-development, and supply agreements with third-party partners.
Support due diligence and regulatory documentation for strategic transactions.
Help define regulatory positioning for silicon nitride’s antipathogenic claims and mechanisms of action, in collaboration with clinical and scientific teams.
Act as a strategic advisor to executive leadership on regulatory and quality matters.
Coordinate external consultants, testing labs, and notified bodies.
Support investor, partner, and board communications related to regulatory milestones and risk posture.