Director of Regulatory Affairs & Quality Control

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.

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.

• Develop and execute U.S. and international regulatory strategies for:
  • Patient-specific and 3D-printed implants (including custom device and personalized device pathways)
  • 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:
  • 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.

• 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
  • Implementation of Greenlight Guru is preferred
• Oversee:
  • Design 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.

• 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.

• 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.

• 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,…