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.
