About Us:

Pictor Labs is at the forefront of innovation in the pathology AI space, delivering cutting-edge virtual staining technologies to enhance the efficiency and precision of histopathology. Our solutions enable pharmaceutical, biotech, and clinical research organizations to unlock deeper insights from tissue samples through advanced, AI driven virtual staining.

Position Overview:

The Director of Quality and Regulatory Affairs plays a critical role in establishing and maintaining Pictor Labs' quality management system, regulatory status, and risk management programs to ensure regulatory compliance and product excellence. This position is responsible for leading a team that develops and implements quality standards, processes, and procedures addressing global in vitro diagnostic regulations, including ISO 13485 and FDA QSR/QMSR requirements. The role coordinates staff supporting regulatory activities including submissions, maintenance, and surveillance for regulated products, laboratory developed tests, and research use only products. The role directly supports our virtual staining panel development and regulatory pathway by ensuring consistent quality standards across all research and development activities, evidence generation, and clinical operations, ultimately enabling successful regulatory submissions, maintenance, and market adoption.

Key Responsibilities:

Quality Management System Management

Lead team that prepares, develops and implements company quality standards, processes, procedures, work instructions, forms, templates, and reports
Establish and maintain a comprehensive Quality Management System aligned with ISO 13485, IEC 62304, FDA QSR/QMSR requirements, and emerging global requirements related to digital pathology and/or artificial intelligence
Execute management responsibility for the implementation of all core QMS processes including, but not limited to document control, training, change control, CAPA, internal audits, and reporting requirements
Develop, review, and assist company leaders to implement SOPs for handling customer property, laboratory operations, and engineering
Support the development of quality metrics and monitoring systems
Monitor and ensure regulatory compliance across all company operations with all applicable US, state, and international laws and regulations

Regulatory Affairs & Compliance

Take management responsibility for coordinating FDA / EU / other submission preparation by ensuring documentation accuracy, completeness, and compliance
Participate in regulatory strategy development for products
Coordinate consultants and employees to assist in executing regulatory goals
Prepare team for and manage internal and external audits
Stay current with regulatory changes and cascade relevant information to the business
Along with marketing, medical affairs, and others in company maintain sign-off procedures and ensure brochures, literature, and web content are accurate and compliant

Quality Assurance & Control

Coordinate team to accomplish quality assurance objectives by monitoring, reviewing, training, and enforcing policies and procedures
Conduct regular quality reviews and internal audits; evaluate data and document deviations from existing standards
Coordinate the execution of CAPA processes with high closure rates and effectiveness
Optimize quality and compliance processes while maintaining cost efficiency
Ensure quality and safety standards are designed and implemented for all clinical evidence generation activities

Risk Management & Process Improvement

Identify areas for improvement across the business, including feedback and training on policy and procedures
Perform risk assessments and implement risk management activities to mitigate business and product risks to satisfy global regulatory / quality requirements
Initiate and lead process improvement projects to enhance quality while maintaining efficiency
Coordinate audits of departmental working practices to reduce/eliminate risks to the business and implement revised practices as needed

Qualifications:

Masters’ degree (or above) in a scientific, engineering, information technology, or management discipline; scientific background essential; diagnostic or medical device experience preferred
Minimum 10+ years of experience in quality and/or regulatory affairs within medical industry
Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and relevant requirements
Experience with quality management system implementation and maintenance
Experience with global regulatory submissions and surveillance
Knowledge of risk management principles (ISO 14971)

Benefits:

Competitive salary with performance-based incentives
Equity participation in a rapidly growing company
Comprehensive benefits package, including health, dental, and vision insurance
Opportunity to work with a talented and passionate team at the cutting edge of pathology AI

This role reports to the Chief Medical Officer and will have direct management responsibility for employees and contractors.

Pictor Labs is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Director of Quality and Regulatory Affairs