Responsible for ensuring full life-cycle regulatory support for $300M men’s interventional urology device portfolio. Collaborated with cross-functional teams, including R&D, quality, and marketing to ensure compliance. Reported regulatory requirements, challenges, and emerging trends to project teams and executive leadership.• Developed and implemented regulatory strategies, including 6 successful US FDA 510(k) submissions, to support business growth and product availability in US market.• Established regulatory plan for quality management system update for SaMD development, ensuring alignment with IEC 62304 standards, facilitating regulatory compliance and adherence to industry best practices.• Maintained professional relationships with external stakeholders (FDA, Notified Bodies, and Competent Authorities), supporting regulatory submissions, field actions, adverse event reporting, and inspections.• Earned Global Regulatory Affairs Spotlight Award (2020) acknowledging outstanding performance and timely regulatory accomplishments during the COVID-19 pandemic.• Received Chairman’s Award (2020) for programming contributions and leadership of Employee Resource Group, organizing events that fostered engagement and diversity.

~Managed 1 Regulatory Affairs Specialist (as Regulatory Affairs Group Lead) to achieve excellence in US and International regulatory compliance and provided expectations for essential duties, responsibilities, and authority. Mentored and developed junior colleagues to ensure essential regulatory strategies were compliant with current standards.~Authored five 510(k) submissions for significant changes to products. Managed updates to EU Technical Files for 16 product families. Managed new and amended Canadian Medical Device Licenses for over 25 product families. Supported regional partners with product specific requirements for OUS regulatory authorizations.~Developed and executed regulatory submission strategies for the United States, Canada, and the European Union to support new and sustaining product development for assigned product families (US Class I and II; CA Class II; EU Class I, IIa, and IIb).~Provide clear communication of regulatory requirements, challenges, and emerging trends to key stakeholders, including executive leadership and project teams.~Ensured compliance with worldwide regulatory requirements for labeling, advertising, and promotional materials.

Developed overarching vision for quality and regulatory processes within a multinational high-speed medical textile manufacturing operation. Led a team comprising 2 Quality Engineering personnel directly and indirectly supervised 9 QC Inspectors, driving the achievement of key performance indicators (KPIs) to uphold and enhance product quality standards throughout the manufacturing process.• Provided clear communication of regulatory requirements, challenges, and emerging trends to project teams and executive leadership, ensuring compliance and preventing manufacturing delays or loss of business.• Managed corporate level Quality System processes and initiatives, including developing and maintaining programs for design control, CAPA, complaints, NCMR, and vigilance systems.

Provided regulatory and quality support for line of pneumatic transport ventilation devices that serviced hospital and EMS departments. Developed Quality System to support company growth and compliance.• Led engineering efforts for new product development, resulting in ventilator technology chosen by GE Healthcare and Ford Motor Company during Covid-19 pandemic to manufacture 50K ventilators in 100 days.• Provided regulatory support, including US regulatory submission, for Continuous Positive Airway Pressure device, receiving Lee Spring Innovation Award in 2008 and increasing company revenue by 95% within 2 years.• Supported development, manufacture, and regulatory clearance of neonatal ventilator, earning EMS World Innovation Award in 2012.