Drives operational excellence to ensure a seamless client experience in a world-class boutique regulatory consulting firm.

Former regulator and industry executive experienced in navigating and interpreting global medical product regulations, policies and best practices. Offering expertise and professional services to the global Health Sciences industries, regulatory bodies, non-profit and public health organizations, including:- Innovative training solutions, operational improvements, global regulatory and go-to-market strategies - Communication strategies, strategic business plans, client and stakeholder… Show more Former regulator and industry executive experienced in navigating and interpreting global medical product regulations, policies and best practices. Offering expertise and professional services to the global Health Sciences industries, regulatory bodies, non-profit and public health organizations, including:- Innovative training solutions, operational improvements, global regulatory and go-to-market strategies - Communication strategies, strategic business plans, client and stakeholder engagement strategies.- Employee development and engagement programs, organizational development and transformation support. Show less

Executed global Go-to-Market and Growth strategies for the $85M Health Sciences Consulting, Training and Certification business. Directed a diverse technical sales and marketing function strategically located across the globe and responsible for $20M in NEW sales. Achievements include:- Reimagined and rebuilt Health Sciences' Sales and Marketing functions to facilitate commercial growth.- Established KPIs, sales goals, commercial operating procedures, and regional sales policies.-… Show more Executed global Go-to-Market and Growth strategies for the $85M Health Sciences Consulting, Training and Certification business. Directed a diverse technical sales and marketing function strategically located across the globe and responsible for $20M in NEW sales. Achievements include:- Reimagined and rebuilt Health Sciences' Sales and Marketing functions to facilitate commercial growth.- Established KPIs, sales goals, commercial operating procedures, and regional sales policies.- Led market research and sales/marketing strategies to support aggressive organic growth in China.- Recognized $2.4M savings by implementing Salesforce CRM across 7 global businesses.- Implemented robust internal communication and employee incentive/engagement programs. Show less

Direct report to the CEO, advisor to the Board of Directors, and member the NSF's Executive Leadership Team. Directed all revenue-generating activities of 6 global Consulting, Training and Certification business units. Led crisis management and corrective actions in the wake of sudden organizational change and significant financial setbacks. Provided interim leadership stability for a specialized global workforce of over 200 diverse experts and maintained relationships with critical clients… Show more Direct report to the CEO, advisor to the Board of Directors, and member the NSF's Executive Leadership Team. Directed all revenue-generating activities of 6 global Consulting, Training and Certification business units. Led crisis management and corrective actions in the wake of sudden organizational change and significant financial setbacks. Provided interim leadership stability for a specialized global workforce of over 200 diverse experts and maintained relationships with critical clients across the Medical Device, Pharma Biotech, Dietary Supplements and Cosmetics sectors. - Created a collaborative and inclusive culture to deliver $85M in profitable revenue. - Maintained all key clients and global experts following significant organizational disruption.- Achieved record-low attrition and increased employee satisfaction by 28% during my tenure. - Developed/presented the 5-year business strategy to Executive Leadership and Board of Directors. - Executed the business operating plan and met goals through effective risk mitigation strategies.- Mentored and onboarded the incoming Health Sciences Vice President. Show less

Created and directed successful B2B Medical Device Training business, boasting NSF's first profitable on-demand e-Learning program. Responsible initially for $10M training revenue, which later expanded to $54M in revenue from all Health Sciences NA professional services. Simultaneously contributed approx. $1M annually for billable Medical Device regulatory expertise. Key accomplishments:- Launched innovative digital training solutions including a cloud-based LMS and E-Commerce platform.… Show more Created and directed successful B2B Medical Device Training business, boasting NSF's first profitable on-demand e-Learning program. Responsible initially for $10M training revenue, which later expanded to $54M in revenue from all Health Sciences NA professional services. Simultaneously contributed approx. $1M annually for billable Medical Device regulatory expertise. Key accomplishments:- Launched innovative digital training solutions including a cloud-based LMS and E-Commerce platform. - Built a broad network of regulatory and technical experts and a solid global base of key clients.- Realized 60% profit margins on training, effectively promoting related auditing and consulting services.- Secured and managed annual operating budgets and business strategies.- Executed global sales, marketing and pricing strategies and product development and delivery plans. - Recruited and directed a diverse team of experts, instructional designers and business operations staff.- Partnered with former regulators and industry leaders to identify relevant training curriculum.- Developed eCommerce and Training sales policies, including global taxation, IP protection, and pricing.- Led the conversion of hundreds of hours of practical classroom training into virtual & blended learning.- Realized $2.4M savings by negotiating early lease termination of NSF's Washington DC office space. Show less

Implemented provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) in various positions of progressive leadership for more than 28 years. Led public awareness and risk communication programs, media outreach, patient and stakeholder engagement, operational improvements, professional development programs, and industry education. Deputy Office Director responsibilities included: - Served as industry liaison and directed novel educational programs for manufacturers, international… Show more Implemented provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act) in various positions of progressive leadership for more than 28 years. Led public awareness and risk communication programs, media outreach, patient and stakeholder engagement, operational improvements, professional development programs, and industry education. Deputy Office Director responsibilities included: - Served as industry liaison and directed novel educational programs for manufacturers, international regulators, and FDA staff.- Established policies and programs to facilitate effective public risk and regulatory communication. - Oversaw the CDRH web, social media, public meetings, and the FDA TV studio/video production facility.- Chaired multiple interagency committees governing internal policy and employee recognition/rewards.- Facilitated Public/Private partnerships and chaired MDIC's Patient & Risk Communication Committee.- Coauthored publications on effective patient communication strategies and safety signal escalation.- Talent management for 160+ employees including recruitment, development, and performance management.- Planned and coordinated large multi-stakeholder events, including cross-country Town Halls and the Internatinal Medical Device Regulators Forum (IMDRF). - Served as FDA and CDRH Mentoring Champion and agency advocate for professional development. - Established novel industry education programs including 'CDRH Learn' and 'Device Advice'.- Executed CDRH’s Continuity of Operations Plan (COOP) and Emergency Response Comm Plan. Show less