Director of Regulatory Affairs & Quality Control

Sintx Technologies Inc • Salt Lake City, UT

3d • Hybrid

About The Position

SINTX Technologies is 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 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 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.

Nice To Haves

• Experience with: o Additive manufacturing / 3D-printed medical devices o Patient-specific or custom medical devices o Biomaterials platforms or materials-science-driven technologies
• Familiarity with: o Antimicrobial or antipathogenic technologies o 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: o Patient-specific and 3D-printed implants (including custom device and personalized device pathways) o Silicon nitride–based wound management, suture, and soft-tissue applications o Biomaterial platforms intended for internal use and third-party licensing
• Lead and manage FDA submissions, including: o 510(k)s, De Novo requests, IDEs, PMAs (as applicable) o 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: o 21 CFR Part 820 (QSR) o ISO 13485 o ISO 14971 (Risk Management) o Applicable ASTM and additive manufacturing standards o Implementation of Greenlight Guru is preferred
• Oversee: o Design and Document controls o Supplier qualification and audits o CAPA, complaints, nonconformance, and change control o 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: o Intended use expansion o New form factors o 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.

Benefits

• SINTX offers a competitive executive compensation package including base salary, performance incentives, equity participation, and comprehensive benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director