Highly driven Regulatory Affairs, Compliance and Quality Executive with over 18 years’ experience in medical device, life science and pharmaceutical industries. Proven leader with significant results reducing worldwide approval timelines while optimizing processes to create an effective Regulatory footprint. Demonstrated strategic focus on business outcomes and building strategic relationships with Senior Health Authority officials. Known for strong communication skills, fostering collaboration and team growth and development. Broad therapeutic experience including, but not limited to, cardiovascular, neurology, orthopedics, ophthalmology, aesthetics, medical imaging, infant care and life sciences.
Leadership and professional highlights include:
- Regulatory: Regulatory strategies, negotiating with regulators, strategic influencing, lobbying, global registrations of new and modified products, annual submissions, advertising and promotional reviews.
- Quality and Compliance: Quality systems, design assurance, quality engineering, microbiology, facilitating regulator audits, complaint handling, global Health Authority reporting, post market surveillance, product recalls and Consent Decree mitigation.
- Management: Leadership of teams ranging in size from 12 to 350+ by providing strategic direction, coaching and mentoring. Due diligence of potential acquisitions and integration of acquisitions.
ADDITIONAL EXPERIENCE
- Head of Global Quality and Regulatory for 350+ team members which included Regulatory Affairs, Quality Systems, Quality Engineering, Design Assurance, Compliance and Micro-Biology functions.
- Global Regulatory leadership 200+ team members responsible for >100 regulated countries.
- Transformed the culture of 6 independent Regulatory teams into a single collaborative Regulatory department resulting in improved business operational performance by 20%.
- Implemented 3 Regulatory Centers of Excellence resulting in a 25% reduction of the Regulatory footprint.
- Effectively optimized key Regulatory processes resulting in achievement of 30+% global submission cycle time reduction with a $2.5M annual savings.
- Executed key influencing strategies in the external, dynamic Regulatory environment to significantly strengthen Health Authority relationships resulting in more face to face interactions and reduction of approvals ranging from 40%-60% depending on the country.
- Developed Regulatory strategic landscape to ensure Regulatory compliance and streamline the submission and approval process resulting in 50% reduction of approvals and increased first pass supplemental approvals.
- Significantly strengthened Health Authority relationships resulting in more face-to-face discussions to resolve complex issues (US, Europe, Korea, China, Japan, Brazil).
- Developed and implemented Global Regulatory Affairs Career ladder resulted in 35% increased team performance.
- Transformed team culture through coaching to instill process ownership while building the team’s confidence. Results included 80% collaboration improvement across the global business.
- Developed Q&A database and submission tools which resulted in reducing Agency review time by >50%. Additional results included output of 300 global submissions within 6 months.
- Further developed the Regulatory team which resulted in >30% reduction of submission timelines and significantly increased business performance.
- Analyzed and integrated 3 Quality Systems resulting in process optimization, faster manufacturing throughput and capability to scale-up production at 10 global plants.
- Created broader Quality System structure to allow autonomy to each facility due to the diverse requirements. In addition drove business process alignment to allow flexibility.
- Built a Regulatory team from the ground up and implemented a RA Center of Excellence resulting in the expansion from 3 geographies to 40+ international markets for a $200M growth.