VP of Regulatory Affairs & Quality Assurance

VP of Regulatory Affairs & Quality Assurance Sintx Technologies Inc - 3.2 Salt Lake City, UT Job Details $180,000 - $225,000 a year 4 hours ago Benefits RSU Qualifications Quality control corrective actions FDA submissions Compliance risk assessment Strategic management Process optimization ISO standards Engineering Supplier quality engineering practices Compliance audits & assessments Six Sigma methodology implementation Corrective and preventive actions (CAPA) Risk mitigation strategy implementation Master's degree Supplier audits Bachelor's degree in engineering Bachelor's degree Continuous improvement 3D printing Regulatory submissions Due diligence Manufacturing Senior level Cross-functional collaboration Lean Six Sigma Certification Cross-functional communication Investor relations New product launch experience 10 years

Full Job Description Description:

Company Overview SINTX Technologies, Inc. is an advanced ceramics and biomaterials company focused on developing, manufacturing, and commercializing next-generation medical device solutions. SINTX is one of a small number of global manufacturers capable of producing ceramic biomaterials for implantable applications, with a platform centered on silicon nitride (SiN) and the next evolution into SiN/PEEK composite manufacturing and patient-specific solutions. Position Summary 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:

Regulatory Affairs Leadership 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 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), 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. Quality Systems & Compliance Own and continuously improve SINTX's Quality Management System (QMS) in compliance with: 21 CFR Part 820 (QSR)

ISO 13485 ISO 14971

(Risk Management) Applicable ASTM and additive manufacturing standards

Oversee:

Design, Process and Document controls Supplier qualification and audits CAPA, complaints, nonconformance, and change control Internal and external audits (FDA, notified bodies, partners) Ensure quality readiness to support scalable manufacturing, clinical use, and partner commercialization. Product Launch & Lifecycle Management Provide regulatory and quality leadership for the launch and expansion of SINERGY™ SiN/PEEK biomaterial, including: Intended use expansion New form factors 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 Platform & Licensing Support 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. Cross-Functional Leadership 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. Qualifications & Experience Required 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.

Highly Preferred Experience with:

Additive manufacturing / 3D-printed medical devices Patient-specific and custom medical devices Biomaterials platforms or materials-science-driven technologies Familiarity with: Antimicrobial or antipathogenic technologies 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 Core Competencies Strategic yet hands-on leadership Strong regulatory judgment and risk assessment Ability to operate effectively in a growth-stage, platform-driven company Clear communicator with executives, regulators, and partners Comfortable balancing innovation speed with compliance rigor

Compensation:

$180,000 - $225,000 base + Bonus + RSU