Company: SINTX Technologies, Inc.

Location: Salt Lake City, UT (On-Site)

Reports to: Chief Executive Officer (CEO)

Works Closely With: R&D, Manufacturing, Clinical, Commercial, Business Development, and External Regulatory Consultants

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 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.

Key Responsibilities

Regulatory Affairs Leadership

• 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.

Quality Systems & Compliance

• 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.

Product Launch & Lifecycle Management

• 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

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 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.

Highly Preferred

• 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

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

Why Join SINTX

• Opportunity to shape regulatory strategy for a differentiated biomaterials platform with strong clinical and scientific foundations

• Exposure to multiple product categories, indications, and commercialization models

• Direct impact on company growth, partnerships, and long-term value creation

• High visibility role working closely with executive leadership

Compensation & Benefits

SINTX offers a competitive executive compensation package including base salary, performance incentives, equity participation, and comprehensive benefits. (Final package is commensurate with experience and market benchmarks for specialized medtech manufacturing leadership.)