Rich m. dujmovic
15 Black Lake Road, North Oaks, MN 55127
u Collaborating with cross-functional partners to create compelling proposals
u Complying with statutory regulations and quality processes
u Working with Worldwide regulators to achieve medical device approvals
u Organizing research, engineering, clinical, and quality resources to address Regulator questions
u Providing team members the tools, resources, advice and encouragement to succeed
u Recognizing individual and team contributions to develop key talent
u Communicating and collaborating with diverse stakeholders geographically
u Establishing future product definitions aligned with organizational goals
BOSTON SCIENTIFIC CORPORATION (BSC)
Rhythm Management (RM), Arden Hills, MN 2001-Present
Vice President, Regulatory Affairs, 2013 to Present
· Lead BSC’s 57-member Cardiac Rhythm Management and Electrophysiology Regulatory Team
· Responsible for Regulatory budget, hiring, personnel organization + development, and project prioritization of product approval strategies in support of $2 Billion annual Divisional revenue
· Team earned approval of “First in their category” Left Atrial Appendage Closure Device, assisting 100,000+ patients, and the Subcutaneous ICD, providing Sudden Cardiac Death protection without utilizing patient vasculature
· Chair an Industry-wide Real World Evidence project in coordination with the US FDA and the National Evaluation System for Health Technology Coordinating Center (NESTcc)
· Selected to lead Boston Scientific’s Regulatory Affairs Steering Committee 2017 and 2018
· Co-Chair of the Medical Device Regulation Migration effort for 26,000 person company
· Achieved FDA Emergency Use Authorization for Covid-combatting Ventilator alternative.
· Led low-voltage US regulatory team (14 direct, 5 non-direct reports) providing support to all low-voltage, Pulse Generator, Leads, and external products worldwide.
· Worked closely with Worldwide regulators; provide ongoing communication and timely responses to expedite the approval process.
· Collaborated with Research & Development, manufacturing, software development, sales and marketing pursuing the launch of new/modified devices.
· Advised due diligence team on regulatory issues and concerns regarding potential acquisitions. Input gave stakeholders greater clarity and ability to make sound business decisions.
· Spearheaded the development and execution of two Experiential Learning Program visits for 12 FDA personnel. Involved 50 company cross-functional personnel. Program generated significant business outcomes – FDA declaring it “the best training ever,” improving progress on key FDA submissions within weeks, and utilizing the successful format for another training program with key Chinese review staffers.
· Initiated and coordinated new annual FDA reporting system in response to regulatory staff needs. FDA lauded the report structure and process. The structure became the new standard for FDA’s Pacing Leads and Defibrillators branch.
· Shared expertise as panel member for Advamed’s and FDA’s 2012 workshop. Discussed risk considerations in assessing product changes, product change strategies, and training cross-functional partners to maximize team’s effectiveness.
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· Obtained BSC/FDA approval of INGENIO prior to 2012 HRS. Met franchise objectives despite late-cycle unsolicited changes to features and programming settings - by creating interactive dialogue with Regulators. Discussed and analyzed changes interactively resulting in prioritized submissions with BSC/FDA leadership.
· Introduced FDA to 3 projects critical to BSC’s future product strategies (HRS 2012). Discussions produced collaborative efforts with FDA and significantly accelerated projects’ regulatory progress.
· Increased staff competence and confidence through deliberate exposure to new products, teams and geographies.
· Presented department’s regulatory perspective at several Patient Safety Advisory Board meetings on regulatory environment changes and impacts.
Manager, US Regulatory Affairs, CRM, 2004-2010
· Led entire 16-person US regulatory team during transition of its 12-year Director.
· Supported submission and approval of a 7-year $300M+ ICD/CRT-D platform.
· Selected (2 times) to present to company’s CEO on US Regulatory Strategy.
· Assisted Corporate Pricing Director and VP of Legal Affairs in developing 2007 CRM contract with Kaiser Health.
· Earned approval for industry-first Radio-Frequency Capable Device Programmer (Zoom Latitude) and Pulse Generator (Renewal 3 RF). Approval ushered in era of daily, remote, and compliance-free patient follow-up.
· Obtained ODE/CDER alignment for reduced Human Clinical Trial requirements through GLP data. Reduced follow-up period 66% with accelerated patient enrollment. Supported trial completion in 4 months.
· Worked closely with regulatory agencies to fully address 11 device recalls. Successfully returned all recalled products to market.
· Managed submission of 1st company-branded ICD and CRT-D incorporating new quality system protocol.
· Helped promotion team with creation/editing of press releases, sales training aids, physician communications, product performance reports, tradeshow content, manuscripts/abstracts and advertising materials.
· Collaborated weekly with cross-functional teams and Office of Device Evaluation (ODE), Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Science and Engineering Laboratories (OSEL), Program Office and IDE staff. Efforts resulted in approvals for leads, Pacemakers, Implantable Cardioverter Defibrillators, Cardiac Resynchronization Therapy Devices (CRT-D), software modifications and external support equipment.
Product Manager, New Product Planning (formerly Guidant Corporation), 2001-2004
· Received 2 Excellence Awards. Rated “Outstanding” performance, 2003 and 2004.
· Developed/implemented business plans and product positioning for 3 CRM products.
· Partnered with Key Opinion Leader physicians, Research, Product Development,
Clinical/Regulatory Affairs, Manufacturing, Finance, Worldwide Marketing and
Sales to ensure optimal employment of company’s capital.
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“Systems, Devices and Methods for Tachyarrhythmia Discrimination or Therapy Decisions.” (2007)
“Pacer with Combined Defibrillator Tailored for Bradycardia Patients.” (2008)
“Modular Anti-Tachyarrhythmia Therapy System.” (2008)
“Method and Apparatus for Question-Based Programming of Cardiac Rhythm Management Devices.”
“Cardiac Rhythm Management System with Defibrillation Threshold Prediction.” (2010)
“AV Delay Features.” (2012)
UNITED STATES AIR FORCE, deployed internationally 1993-2001
Captain, Navigator/Electrical Engineer
Mission Employment Flight Commander/Executive Officer, 1999-2001
Wing Weapons and Tactics Instructor Navigator
Deputy Chief, Standardization/Evaluation,
Evaluator Navigator, 1998-1999
Assistant Chief, Squadron Aircrew Scheduling/Instructor Navigator, 1997-1998
Squadron Training Officer/Navigator, 1994-1997
Foreign Air Defense Command, Control, Communications (C3) Systems Engineer, 1993-1994
University of Colorado, Boulder, CO
Master of Engineering degree, Engineering Management 2000
US Air Force Academy, Colorado Springs, CO
Bachelor of Science degree, Electrical Engineering 1993
Coached Little League, All-Star & Traveling Baseball, Traveling Basketball & Soccer, 1999-2013
Coon Rapids National Little League Board of Directors, 2009-2012
Served Church as Board Member, Youth Group Leader and Sunday School Teacher, 2005-2011
American Heart Association – Heart Walk Executive Sponsor and Chief Fund Raiser, 2015-2017
STARBASE Minnesota – Board of Directors, 2017-present
Executive Sponsor - Veterans Employee Resource Group, 2016-present