Job Description
Description
Company: SINTX Technologies, Inc.
Location: Salt Lake City, UT (On-Site)
Reports to: Chief Executive Officer (CEO)
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.
Requirements
Regulatory Affairs Leadership
- 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.
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 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.
Required
Qualifications & Experience
- 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:
- Additive manufacturing / 3D-printed medical devices
- Patient-specific or 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
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.)