Regulatory Affairs and Quality Specialist

Job Description

Location: Frisco, Texas (Onsite)

About NanoCure AI Company

NanoCure AI Company is developing a first of its kind AI driven cellular analysis platform designed to detect, classify, and ultimately enable earlier diagnosis and treatment of hematologic cancers and other blood borne diseases. Our initial software platform will launch as a research use only system while we build toward FDA clearance as a clinical diagnostic Software as a Medical Device.

This is a ground floor opportunity to help architect and implement the regulatory and quality infrastructure that will enable FDA clearance, clinical adoption, and global scale.

Position Overview

NanoCure AI Company is seeking a Regulatory Affairs and Quality Specialist to own and implement the company’s regulatory and quality systems. This individual will be responsible for establishing and maintaining an ISO 13485 compliant Quality Management System, implementing ISO 14971 risk management processes, and supporting the company’s FDA regulatory strategy including Pre Submission preparation and eventual regulatory submissions.

This role will work directly with executive leadership, software engineers, clinical advisors, and external regulatory consultants to ensure the company’s software platform is developed in compliance with FDA and international regulatory requirements.

This is a critical foundational role that will directly enable the company’s transition from research use only software to FDA cleared diagnostic Software as a Medical Device.

Key Responsibilities

Quality Management System Implementation and Maintenance

• Establish and maintain an ISO 13485 compliant Quality Management System aligned with FDA Quality System Regulation requirements
• Develop and manage core quality procedures including:
  • Design controls
  • Document control
  • Change control
  • Training management
  • Corrective and preventive action procedures
  • Supplier qualification and management
  • Software development lifecycle procedures
• Maintain complete and audit ready Design History File documentation
• Ensure all development activities are properly documented and traceable
• Maintain training records and ensure personnel compliance with quality procedures
• Support internal audits and external regulatory inspections as needed

Risk Management (ISO 14971)

• Establish and maintain the company’s risk management process
• Develop and maintain risk management files including:
  • Risk management plan
  • Hazard analysis
  • Risk evaluation and scoring
  • Risk mitigation documentation
  • Residual risk analysis
  • Risk management reports
• Work with engineering and clinical teams to identify and mitigate software and clinical risks
• Ensure risk management is integrated into product development lifecycle

Regulatory Strategy and FDA Interaction Support

• Support preparation of FDA Pre Submission packages
• Assist in defining regulatory pathway including 510k or De Novo classification strategy
• Prepare and maintain regulatory documentation including:
  • Device description
  • Intended use and indications for use
  • Software documentation
  • Validation plans
• Support preparation of regulatory submissions including 510k or De Novo applications
• Monitor and interpret FDA guidance relevant to Software as a Medical Device and AI based diagnostics
• Maintain regulatory compliance documentation

Software Development and Design Control Support

• Work closely with software and machine learning engineers to ensure compliance with design control requirements
• Maintain requirements traceability matrix
• Ensure software verification and validation documentation is properly maintained
• Support implementation of software lifecycle processes aligned with regulatory requirements

Cross Functional Collaboration

• Work closely with executive leadership to develop regulatory strategy
• Collaborate with engineering teams to ensure compliant development practices
• Coordinate with clinical advisors on validation strategy and documentation
• Support external regulatory consultants as needed
• Help prepare the company for future FDA inspections and regulatory submissions

Qualifications

Required

• Bachelor’s degree in regulatory affairs, biomedical engineering, life sciences, or related field
• Experience working with medical device Quality Management Systems
• Working knowledge of ISO 13485 and FDA Quality System Regulation
• Working knowledge of ISO 14971 risk management principles
• Experience supporting regulatory submissions or regulatory documentation
• Strong documentation and organizational skills
• Ability to work independently and build systems from early stage
• Strong attention to detail

Preferred

• Experience with Software as a Medical Device
• Experience with AI or machine learning based medical software
• Experience supporting FDA Pre Submission, 510k, or De Novo submissions
• Experience implementing or maintaining ISO 13485 Quality Management Systems
• Experience in diagnostic or digital pathology software
• Experience working in startup environments

Impact of This Role

This individual will directly enable NanoCure AI Company’s transition from research use only software to FDA cleared diagnostic platform. The regulatory and quality infrastructure implemented in this role will form the foundation for regulatory approval, clinical deployment, and commercialization.

Compensation

Pre-funding is equity compensation to begin. Up to 1% equity.

Post funding salary to be discussed during hiring process.