Dana Hutcheson Email & Phone Number

Denver, Colorado, United States

• Responsible for all regulatory compliance, licensing, reporting, and planning for a network of marijuana and hemp laboratories• Ensures that all regulatory requirements are met on an individual state basis • Ensures that each laboratory develops and uses an appropriate quality system approach to laboratory testing that provides accurate and reliable test results• Provides leadership in regulatory activities to promote a complete state of compliance in incumbent and future testing operations• Responsible for licensing and regulatory compliance to CDPHE, MED, ISO, AOAC, as well as 50 state compliance• Monitors state and federal level developments regarding hemp and marijuana regulations• Informs Executive Leadership of issues, concerns, or problems that might lead to regulatory non-compliance before they happen• Liaises with regulatory officials and is responsible for submissions to and any ongoing communication with regulatory bodies• Liaises with legal counsel to ensure any ambiguous regulations are assessed for risk• Assists in budget development for the department• Develops, monitors, and makes continuous improvements in the regulatory department based on KPIs and other metrics• Participates in regulatory and partner audits as required• Develops our next generation of leaders through mentorship, training, coaching, and feedback.• Works with R&D to efficiently transfer method changes, updates, and developments into laboratory practice.

Denver, Colorado, United States

• Strong understanding of laws and regulations that govern the hemp and adult-use cannabis industries on an individual state basis• Monitors state-level developments regarding cannabis regulations and coordinates relationships with key state-level regulators• Reviews all testing data and Certificates of Analysis to ensure compliance with state-specific requirements• Maintains all registrations, licenses, and contracts or other agreements with key partners• Performs regulatory research relating to the industry and monitors state level regulations and associated developments• Builds and maintains strong business relationships with targeted stakeholders• Works with QA to develop internal laboratory facilities and processes• Actively manages contracts, agreements, RFPs, and project execution with key partners and regulatory bodies• Works directly with internal and external laboratories and other test houses for new product development and lot/batch release• Collaborates with business unit management to ensure alignment with regulatory frameworks• Participates with internal stakeholders in the assessment of regulatory risks and business opportunities• Ensures all compliance requirements are met in accordance with state and federal laws• Liaises with regulatory officials and prepares regulatory submissions• Responsible for site specific document control functions• Final review and approval of all product labeling and promotional materials• Final review and approval of all formulations for compliance with regulatory and commercial requirements

Boulder, Colorado, United States

• Project Manager for a multifaceted recertification effort• Project leadership includes scheduling, negotiation, contract review, communication, cost control, and delivery• Responsible for correspondence with the notified body and creation of documentation to respond to NB requests• Works closely with the engineering team to determine and execute appropriate device changes• Prepares notification documents, change summaries, technical documentation, and essential requirements for submission• Subject Matter Expert for standards compliance for sterilization, reprocessing, biocompatibility, human factors, risk management, and labeling.

Aurora, Colorado, United States

• Responsible for implementing, maintaining, and improving the Quality Management System, including SOPs, Work Instructions, Test Protocols and Reports, Risk Management, Design & Development documents, labeling, etc.• Responsible for all Regulatory Program Management activities• Ensures compliance with the company quality standards, FDA regulations and guidance, applicable EU Medical Device Directives/Regulations, and applicable ISO standards• Collaborates with design partners, vendors, and suppliers in defining, managing, and integrating their quality system documents and records into the QMS• Develops and maintains product and subsystem requirements to ensure they are unitary, complete, consistent, traceable, feasible, unambiguous, testable, and verifiable. Supports the traceability of risks and requirements to execution of verification.• Works closely with the engineering team to develop Verification & Validation Plans and test protocols • Ensures that all Software Verification & Validation activities are followed, including low-level unit testing adequate to the level of concern and all configuration management, build, release, and version control methods• Prepares approval applications and technical documentation for Regulatory and Compliance Agencies• Conducts and participates in internal audits of the Quality System and continuous improvement initiatives• Performs and coordinates supplier audits and assessments of suppliers’ Quality Systems and expected QMS deliverables, as well as suppliers’ manufacturing processes, documentation, and expected product yields• Oversees inspection documentation and incoming inspection of materials• Coordinates Regulatory and Compliance Agency audits

Denver, Colorado, United States

• Lead Quality Auditor for all internal, external, and supplier audits ensuring FDA and EPA compliance for:o Medical management contact centero Pharmaceutical information provisiono Safety and adverse event reportingo Quality reportingo Clinical trialso Researched Abuse, Diversion and Addiction-Related Surveillance • Support for developing procedures related to drugs, drug devices (combination products), vaccines, nutraceuticals, and consumer products• Management of nonconformance process: Root Cause Analysis and resolution of CAPAs, Non-Conformances, Planned Deviations, and Complaints• Maintenance of document control and quality record retention• Change control including data center and software validation• GDPR Implementation Lead• eQMS vendor selection, customization, and validation

Denver, Colorado, United States

• Primary auditor for all internal, external, and supplier audits ensuring full compliance too FDA quality, good tissue practice, and Medicare regulationso United Network for Organ Sharing policieso Association of Organ Procurement Organizations standardso American Association of Tissue Banks standardso OSHA regulations• Monitored and analyzed changes in legislation and standards and made recommendations for procedural changes• Developed new supplier qualification, laboratory submission, and environmental monitoring procedures• Developed new modules for internal software programs to monitor CAPAs, NCRs, complaints, and deviations• Managed the Approved Supplier List and agreements/contracts• Reviewed reactive serology results from organ and tissue cases and reported results to appropriate agencies• Provided document control support• Performed several equipment and software validations

Boulder, Colorado, United States

• Sole regulatory resource for o Domestic, foreign, and standard certifications, accreditations, registrations, submissions, and communication; US, Canada, EU, South Korea, Israel, KSA, Chileo Management of Technical Documentation and implementation of new Notified Body (CE Marking)o MAUDE database management and Medical Device Event Reportingo US Certificates to Foreign Governmentso Regulatory and standards research/reconnaissance and compliance declarationo Authorized Representative contract negotiation• Lead Internal Auditor• FDA preparation/training and audit “back room” manager• Resolution of many CAPAs and root cause analyses• Approved Supplier List management, supplier audits, and quality agreements/contracts• Led the implementation of the Restriction of Hazardous Substances (EU), Unique Device Identifier (US), Electronic Medical Device Reporting (US), electronic record (US), and Conflict Minerals (US) regulations• Developed Key Performance Indicators, organizational goals, and Quality Metrics for critical systems• Redeveloped systems and procedures for recall, risk management, post-market surveillance, regulatory research, software validation, document management, new associate orientation, Quality Management System organization• Extensive knowledge of shipping practices for infectious medical goods and batteries (DOT regulations)• Thorough experience with Non-Conforming Materials management and incoming/in-process/final inspection• Change Notice and Product Release approver• Key member of Management Review and organizational priority evaluation• Company liaison at industry events

Lakewood, Colorado, United States

• Quality review, DHF maintenance/remediation, and cross-functional “Voice of Quality” team resourceo Automated Blood Collection System and accessories Software, equipment, and disposable development projectso Automated Collections application software productso Transfusion solutions (anti-coagulant, blood product storage solutions)o Custom MDDS development for customer information systemso DEHP/BPA free product development for solutions and disposableso Terumo Medical Corporation device acquisition and manufacturing location changeso Distributed and contract manufactured productso Internal software applications and tools (datalog, service software, managed feature options) • Principal driver of I&D process improvements (training, change orders, test method validation, statistical methods)• Leader of the Design Control Coaches Network and team lead for the development of a new design control process• Provided direction to design teams on application of methodologies and best practices in design activities including development of product requirements, statistical methods, design verification and validation, and process validation• Development and execution of Human Factors/Usability Studies• Key member of the Risk Management Team and developer of current Lifecycle Risk Management Procedureo Extensive knowledge of Medical Device Risk Management and Human Factors/Usability Engineering• Root Cause Analysis and resolution of CAPAs• Development and execution of training and awareness programs (ISO 14971, Stability Testing, Design Control, Requirements, Cybersecurity, Human Factors/Usability Engineering)• Developed Technical Files and Declarations of Conformity• Quality audits of Design History Files and Technical Files• “Hot-seat” audit resource with notified bodies, backroom with FDA• Document control system development and administration• Engineering Change Order and Product Release approver• Company representative at industry events