SINTX (NASDAQ: SINT) · 3 hours ago
Director of Regulatory Affairs & Quality Control
West Valley City, UT
Full-time
Hybrid
Director/Executive
10+ years expSINTX Technologies, Inc. is an advanced ceramics and biomaterials company focused on developing, manufacturing, and commercializing next-generation medical device solutions. They are seeking an experienced Director of Regulatory Affairs & Quality Control to lead global regulatory strategy and quality system execution across their biomaterial platforms, ensuring compliance and supporting product launches.
BiotechnologyHealth CareMedical Device
Responsibilities
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
Qualification
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
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
Benefits
Performance incentives
Equity participation
Comprehensive benefits
Company
SINTX (NASDAQ: SINT)
SINTX is an OEM ceramics company that develops and commercializes advanced ceramics for medical applications.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$207.88MKey Investors
National Institutes of HealthCrede CapitalGroupHercules Capital
2025-09-08Post Ipo Equity· $3.8M
2025-02-26Post Ipo Equity· $5M
2024-04-03Post Ipo Equity· $1.5M
Leadership Team
B. Sonny Bal
Chairman of the Board
Bryan J. McEntire
Chief Scientific Officer
Recent News
2025-12-01
2025-11-14
Company data provided by crunchbase