David Pudwill Email and Phone Number
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Seeking senior leadership opportunities to support small and medium sized FDA-regulated companies.A passionate and driven senior leader with nearly two decades of regulatory, quality and clinical experience at FDA and in the medical device, IVD and combination product industry, including implantable Class III devices, extracorporeal and drug delivery systems and biologic products. Responsibilities as head of large and small multi-functional teams, with success resolving significant quality and regulatory challenges for billion-dollar companies and early-stage medical technology startups. Invested in innovative approaches to bring transformative products to market, improve outcomes and enhance patient lives.Interested in reforming health policy decision-making to improve health outcomes, and finding ways to better integrate dietary changes into treatment and prevention of acute and chronic illnesses.
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President And CeoPrather Biomedical CorporationOrlando, Fl, Us
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Instructor, Regulatory Submissions For Medical DevicesUc San Diego Extended Studies Jun 2024 - PresentLa Jolla, Ca, Us -
Principal ConsultantFda Blueprint Mar 2024 - PresentBased in the heart of Silicon Valley, FDA Blueprint specializing in fractional leadership support for regulatory, quality and clinical teams at small and medium-sized medical device and combination product companies. -
Medical Sales DirectorPrather Ranch Mar 2023 - PresentBovine tissue harvesting, including bone and collagen-rich materials. -
Principal ConsultantMr Regulatory Apr 2021 - PresentMr Regulatory is a California based corporation specializing in medical device regulatory education and consulting services.• Providing training resources and regulatory and quality support for PMAs, 510(k)s, IDEs, and pre-submissions to FDA.• Ex-FDA advice on regulatory strategy, as well as hands-on guidance for navigating challenging FDA interactions.• Successful 510(k)s, Q-subs, IDE submissions, and preparation for FDA inspections and audits for various clients.Primarily assisting small and medium sized medical device startups. -
ProfessorMr Regulatory Aug 2020 - Apr 2021Produced educational videos and other content: https://www.youtube.com/c/MrRegulatory
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Regulatory ConsultantAscentx Medical Apr 2023 - PresentSupporting FDA Submissions.
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Senior Vice President, Head Of Regulatory AffairsAscentx Medical Apr 2021 - Mar 2023Led engagement with FDA and submission of PMA Modules, IDEs and Q-subs.
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Senior Director, Regulatory AffairsConvatec Sep 2020 - Apr 2021London, England, GbChampioned new ways of thinking about regulatory affairs for in-market support, new product development and digital transformation within the Technology and Innovation team at Convatec.Led team of 11 regulatory specialists based in US, Canada, and UK, supporting global ostomy business and responsible for interactions with US FDA and Health Canada across business units.• On track for successful EU MDR implementation for ostomy business in 2021, a multi-year cross-functional effort, and completed MDR transition for EuroTec in April 2021.• Completed systems and process optimization project in 2020, prepared for Regulatory Information Management System implementation, and established key process indicators. -
Senior Director, Ostomy Franchise Regulatory Affairs And Quality AssuranceConvatec Nov 2018 - Aug 2020London, England, GbLed and mentored global team of over 100 regulatory, quality, clinical, and engineering specialists based in US, Canada, UK, and at manufacturing sites in Dominican Republic and Netherlands. Achievements• Set strategy for consolidating 46 design files into 13 technical files as part of EU MDR effort.• Enabled manufacture and evaluation of innovative ostomy pouch using agile regulatory approach.• Reduced global complaints at our largest manufacturing site by more than 20% over 18 months.• Drove manufacturing quality improvement and a global market action to address a safety issue.
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Director, Regulatory Affairs And Quality Assurance, AmericasConvatec Jan 2017 - Oct 2018London, England, GbLed a regional team of 15 regulatory and quality specialists in US, Canada, and Latin America.Achievements• 510(k) clearances, resolving biocompatibility, microbiology, human factors, and EMC concerns for combination product wound dressing and negative pressure wound therapy devices.• Led FDA interactions for new product development, supporting eight 510(k)s and six Q-subs.• Successfully managed four global product recalls, and several additional market actions.• Reduced regulatory spend by 10% in Latin America in 2018 without reducing headcount.
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Lead Medical Device Reviewer, Biomedical EngineerFda Jan 2008 - Jan 2017Silver Spring, Md, UsLed cross-disciplinary teams of 2 to 15 to review PMAs, IDEs, 510(k)s, de novos and HDEs. Regularly served as acting branch chief, mentoring and leading 10 to 15 members of our group. Achievements• Provided cross-agency regulatory support for DARPA Dialysis-Like Therapeutics Project.• Supported Advisory Committee Meetings that expanded obesity device PMA approvals. • Reviewed hundreds of medical devices, including software and combination product reviews: o CBER and CDER-led review of cell-based products, drugs and swallowable devices, o CDRH-led review of combination products and drug administration during dialysis, o Lead reviewer of organ preservation and dialysis devices, catheters, stents, weight loss, GERD, and electrical/surgical devices, as well as other gastroenterology and renal devices. -
Chief (Acting), Implantable Electrophysiology Devices BranchFda Nov 2015 - Apr 2016Silver Spring, Md, UsLed team of 13 direct reports, including three MDs, in review of ICDs, pacemakers, steroid eluting leads, and heart failure devices. Facilitated regular communication between FDA and companies. Achievements• Ensured timely quality review of hundreds of PMAs, IDEs, 510(k)s, 513(g)s, and pre-submissions.• Successful FDA Panel Meeting resulting in PMA approval of two novel Leadless Pacemakers.• Brought team through transitional period to a place of long-term stability under new leadership. • Mentored and empowered a team with limited experience, and implemented IT enhancements.
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Congressional Affairs Specialist (Detail)Fda Jan 2015 - May 2015Silver Spring, Md, UsPrepared FDA leaders for Congressional Hearings, held briefings with Congressional staff, and wrote letters responding to concerns raised by Members of Congress and their constituents.Achievements• Engaged with FDA stakeholders on dozens of 21st Century Cures Legislative Proposals.• Arranged and prepared FDA leadership for more than 20 meetings with members of Congress.• Led FDA effort of responding to congressional inquiries about ERCP duodenoscope infections.
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Field EngineerSt. Jude Medical Jun 2006 - Aug 2007St. Paul, Minnesota, UsAssisted physicians at initial ICD and pacemaker implantations. Interacted with patients and physicians while conducting device assessments and troubleshooting in ORs, hospitals and clinics. Evaluated hundreds of pacemakers and implantable cardioverter-defibrillators (ICDs) as sales team technical expert. -
Summer Research InternCase Western Reserve University Jun 2005 - Aug 2005Cleveland, Oh, UsDesigned and constructed an electrochemical setup, modified Atomic Force Microscope (AFM) for liquid use, obtained cyclic voltammetry readings, and developed an improved microchip array design.
David Pudwill Skills
David Pudwill Education Details
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The Johns Hopkins UniversityMechanical Engineering -
Case Western Reserve UniversityBiomedical Engineering
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Harvard Business School OnlineOther; "Core: Credential Of Readiness"
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Eastview High School
Frequently Asked Questions about David Pudwill
What company does David Pudwill work for?
David Pudwill works for Prather Biomedical Corporation
What is David Pudwill's role at the current company?
David Pudwill's current role is President and CEO.
What is David Pudwill's email address?
David Pudwill's email address is da****@****tec.com
What is David Pudwill's direct phone number?
David Pudwill's direct phone number is +165189*****
What schools did David Pudwill attend?
David Pudwill attended The Johns Hopkins University, Case Western Reserve University, Harvard Business School Online, Eastview High School.
What are some of David Pudwill's interests?
David Pudwill has interest in Children, Spending Time With Family, Cooking, Disruptive Technology And Innovations, Politics, Education, Racquetball, Reading, Science And Technology, Faith.
What skills is David Pudwill known for?
David Pudwill has skills like Medical Devices, Leadership, Fda, Biomedical Engineering, Research, Clinical Research, Project Management, Leadership Development, Data Analysis, Regulatory Affairs, Public Speaking, Team Leadership.
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