David Pudwill Email & Phone Number

Orlando, FL, US

La Jolla, CA, US

Based 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.

Bovine tissue harvesting, including bone and collagen-rich materials.

• Mr 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.

Produced educational videos and other content: https://www.youtube.com/c/MrRegulatory

Supporting FDA Submissions.

Led engagement with FDA and submission of PMA Modules, IDEs and Q-subs.

London, England, GB

• Championed 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.
• 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.

London, England, GB

• Led 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.

London, England, GB

• Led 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.

Silver Spring, MD, US

• Led 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.

Silver Spring, MD, US

• Led 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.

Silver Spring, MD, US

• Prepared 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.

St. Paul, Minnesota, US

Assisted 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.

Cleveland, OH, US

Designed and constructed an electrochemical setup, modified Atomic Force Microscope (AFM) for liquid use, obtained cyclic voltammetry readings, and developed an improved microchip array design.

Master'S Degree, Mechanical Engineering

Bachelor Of Science (Bs), Biomedical Engineering

Other; "Core: Credential Of Readiness"

Education record