Director of Regulatory Affairs & Quality Control at SINTX

Salt Lake City, Utah, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Apr, 26

Salary

0.0

Posted On

28 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Control, FDA Submissions, Risk Management, Quality Management System, Additive Manufacturing, Biomaterials, Lean Six Sigma, Clinical Collaboration, Product Launch, Lifecycle Management, Cross-Functional Leadership, Strategic Planning, Supplier Audits, Post-Market Surveillance, Compliance

Industry

Biotechnology Research

Description

Description Company: SINTX Technologies, Inc. Location: Utah (Hybrid or On-Site Preferred) 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. Requirements 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.)

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Responsibilities

The Director of Regulatory Affairs & Quality Control will lead global regulatory strategy and quality system execution for SINTX's biomaterial platforms. This includes managing FDA submissions, ensuring compliance with quality standards, and supporting product launches and lifecycle management.