Director of Regulatory Affairs & Quality Control
The American Ceramic Society, Salt Lake City, Utah, United States, 84193
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:
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
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.
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.
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: 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.)
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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:
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
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.
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.
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: 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.)
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