Director of Regulatory Affairs & Quality Affairs

Company

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.

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

• 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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