• Senior Regulatory & Compliance leader with oversight of diverse team responsible for domestic and international product & trade compliance for a broad product portfolio.• Responsible for the development, management, and application of regulatory processes & strategies and the development and maintenance of policies & procedures to ensure compliance with FDA, EPA, DEA, DOFWS, UDSA, and other global regulatory requirements.• Responsible for domestic and international submissions, registrations, certifications, and licenses for products used in highly regulated industries including medical devices and in-vitro diagnostics, active pharmaceutical ingredients, excipients, long and short-term implantable materials, listed/precursor chemicals, cosmetic ingredients, aerospace, defense, and electronics materials. • Oversight of US, Canada, and Mexico import and export trade compliance including Free Trade, duty management & recovery, governance & risk, classification, and policy & procedure.• Management of global regulatory aspects of new product development and supply chain distribution including US and foreign regulatory clearance/approvals for worldwide commercial distribution.

• Generation and refinement of Quality Systems procedures and workflows including Validation, Customer Complaints, Field Action, Non-Conformances, and CAPA including the introduction of risk-based processes.• Collection and analysis of data for measurement of product quality and organizational performance.• Project leader for validations leading to regulatory submissions including a novel excipient.• Development and implementation of ISO13485/21 CFR 820 compliant design controls process.• ISO 10993 biocompatibility testing, risk management, qualification and validation activities including master validation plans, equipment and facility qualification, process validation, and ISO 14644 cleanroom validation.• Development of ISO14644 compliant ISO Class 7/8 cleanroom procedures including environmental monitoring.

• Development of validation and operation solutions for storage, manufacturing, analytical analysis, and monitoring equipment within the pharmaceutical and medical device industries.• Use of design of experiments and statistical data analysis to ensure robust and compliant validation of equipment and processes.

• Lead Quality Engineer for multiple 510k, PMA and HDE medical device product families.• Responsible for disposition of non-conformances and review and approval of change orders.• Project leader for multiple regulatory submissions including site change, process and design changes, and annual reports. Key participant in successful FDA site inspections.• Lead investigator and cross-functional team leader for root cause analysis within CAPA and complaint systems including development of HHE for FDA review.• Development and maintenance of risk assessment libraries and risk management activities including dFMEA and pFMEA in accordance with ISO 14971.• Development, validation, and monitoring of processes and equipment in PMA medical device manufacturing.• Statistical analysis of data and design of experiments.• Maximization of equipment usage, process efficiency, minimizing scrap/rework rates.