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

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

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.
• Works closely with the engineering team to develop Verification & Validation Plans and test protocols

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.
• 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

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.
• 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

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.
• 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

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.
• 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.
• 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