Dennis Shay, Ph.D., RAC-Devices

Experience

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  Penn State University

  Sept 2003 - May 2005

  Undergraduate Researcher

  Undergraduate honors research on the verification of a proposed model for eliminating stress and corrosion cracking in nuclear reactor containment vessels. Performed statistical analysis of anodic passive film growth thickness on Zircaloy alloys, operated and maintained a hydrodynamic electrochemical corrosion vessel, and performed electrochemical measurements using Z-Plot and Corrware.

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  ACMI

  May 2004 - Aug 2004

  R&D Intern

  ACMI Co. technician internship for failure testing and analysis of biomedical devices used in the urological and gynaecological diagnostic industry. Instron used for failure testing in tension and compression. Performed reliability/wear test method development and implementation. Learned engineering change orders, protocol revisions and data used for FDA submissions.

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  Millipore

  May 2005 - Aug 2005

  Quality Control Engineering Intern

  Internship in the quality engineering department at Millipore Co., focused on filtration systems for the research and biomedical industry. Performed statistical gap analysis of batch data for detection of production flaws, created production flow charts for updates to production lines, made protocol revisions of erroneous and out of date documents, and did database gap analysis and revisions.

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  Penn State University

  Jan 2007 - Aug 2007

  Research Assistant

  Research assistant in Dr. Elizabeth Dickey research group working for Anton V. Polotai.

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  Penn State University

  Aug 2008 - Feb 2014

  NDSEG Fellow

  Doctor of Philosophy (Ph.D.), Materials Science and Engineering Thesis Title: "Development and Characterization of High Temperature, High Energy Density Dielectric Materials to Establish Routes towards Power Electronics Capacitive Devices"Thesis Advisor: Dr. Clive Randall

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  NeedleTech Products, Inc

  Feb 2014 - Feb 2016

  Quality and Regulatory Affairs Engineer

  Specialized in validation and verification of state-of-the art medical device manufacturing process equipment, process control, and preparation and submission of 510(k)s for a medium-sized medical device contract manufacturer specializing in custom needles, cannulas, and stylets, along with specialized overmolding capabilities.

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  PHASE(n)

  Feb 2016 - Feb 2018

  Quality Assurance and Regulatory Affairs Manager

  Specialized in quality systems development, management, and continuous improvement as well as maintaining of regulatory compliance and certifications for a small medical device contract manufacturer specializing in the aesthetics and pain management industries.

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  Cardinal Health

  Apr 2018 - Mar 2020

  Principal Regulatory Affairs Specialist

  Responsible for providing regulatory support for the Patient Recovery team including change development projects, change assessment, domestic and international submissions including Class III PMA and Technical Dossiers / Summary Technical Documentation, commercial support, manufacturing support, compliance-related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient Recovery Business.

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  Insulet Corporation

  Mar 2020 - May 2022

  Regulatory Affairs Manager

  Managed all regulatory aspects for US and International product launches and maintenance, including Omnipod and Omnipod DASH. This includes Class II and Class III (US), Class IIb and Class III (EU), and Class II and Class III (Canada) device systems. Attention to safety, efficacy, compliance, substantial equivalence, design control, change control, manufacturing, and post market activities are all essential to this role. Responsible for regulatory compliance for the commercialized Omnipod system and the recently launched Omnipod DASH system. This includes providing regulatory leadership for all design changes, maintaining technical files, and MDR transition. Also responsible for managing the advertising and promotional material approval process and working with the commercial team to achieve business objectives and maintain compliance. Show less

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  3EO Health

  May 2022 - Nov 2024

  Head of Regulatory, Clinical, and Quality Assurance

  Member of the Senior Leadership Team reporting to the CEO. - Currently furloughed (financial)Leading Regulatory Affairs for 3EO Health, a “Point of Life” diagnostic company leveraging novel diagnostic technology to power a digital wellness engine. We enable people to thrive by extending the four walls of the health system into the home, work, and community. Our passion is to create a world where every person is empowered to optimize their health.

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  ICON plc

  Dec 2024 - now

  Director of Quality - ISO 13485

  Responsible for designing, implementing, and maintaining an ISO 13485-compliant Quality Management System for ICON's Central and Special Laboratories as they tackle their FDA LDT Rule, IVDR transitions, and overall journey into Global IVD manufacturing.