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Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLEExperienceI have 19 years of experience providing full lifecycle regulatory, quality, and technical writing support to life science and government organizations developing, upgrading, or maintaining software systems, medical devices, Platform as a Service (PaaS), Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), wearables, and apps, including those utilizing artificial intelligence (AI) and machine learning (ML). With 12 years of experience in private sector management consulting, I also have deep expertise in business development, proposal composition, RFI and RFP response composition, technical writing, and deliverable editing. In my recent projects, I have Provided software SME and technical writing support on a multiple-round gap assessment of software- and QMS-related documentation for an AI-powered radiology SaMD FDA 510(k) submission against US regulations and IEC / ISO standards; reviewed and authored extensive technical and regulatory feedback on all verification testing (unit, integration, system) documentation for an Investigational Device Exemption(IDE) submission to FDA for a U.S. companys Class III Left Ventricular Assist Device(LVAD); conducted research and authored a Cell & Gene Therapy (CGT) regulatory and reimbursement landscape assessment covering 11 geographic regions for a Japanese CGT developer; reviewed and provided extensive FDA regulatory feedback on software development, human factors, and risk management documentation for a large U.S pharma seeking U.S. regulatory clearance for its insulin autoinjector with smart cap that connected via Bluetooth to a tracking / dosing app; provided software SME and technical writing support a U.S. client with a PaaS system on a 21 CFR Part 820- and ISO 13485-compliant Quality System build and generation of records needed for filing a Master File (MAF) with FDA; and provided software SME and technical writing support to a U.S. company seeking to align its Quality SOPs with requirements of FDAs QMSR Final Rule. In addition, I have provided backend support to experts retained by counsel in U.S. state and federal lawsuits concerning medical devices and pharmaceuticals. I have also served as lead technical writer on FDA pre-submissions and submissions, regulatory opinions, design history file assessments, scientific literature reviews, site- and corporate-level responses and updates to FDA for Warning Letters, combination product benchmarking studies, and quality system remediation plans.I am a member of the Regulatory Affairs Professionals Society (RAPS) and American Society for Quality(ASQ).Product Expertise SaMD SiMD PaaS Government Software Systems Medical Devices Companion Diagnostics Clinical Decision Support In Vitro Diagnostics Remote Clinical TrialsFunctional Expertise Design Controls Medical Device Reporting Quality System Design, Update, and Remediation Regulatory Assessments Regulatory and Quality System Gap Assessments Software Development Lifecycle Management Software Verification & Validation Submissions Technical Writing Proposal, RFI response, and RFP response development Marketing collateral Pitch decksPublications Woywod, Bill, Candidate's Name , and Jacob Graham, Four Critical Considerations for Launching Digital Diagnostic Tool, Pharmaceutical Executive, October 14, 2021. Thiel, Scott, and Candidate's Name , Medtech Needs A Clearer Regulatory Definition of Clinical Decision Support Software, Med Device Online, May 24, 2017. Thiel, Scott, Jennifer Mitchell, and Candidate's Name , Coordination or Collision? The Intersection of Diabetes Care, Cybersecurity, and Cloud-Based Computing, Journal of Diabetes Science and Technology, October 26, 2016. Thiel, Scott, Candidate's Name , and Sarah Baumann, When to File a New 510(k): Two New Draft Guidances Provide Greater Insight, Navigant Client Publication, October 25, 2016. Hittle, Colleen, Candidate's Name , and Stephanie Lewko, 3 Key Sources of Data-Related Compliance Risk (And How to Fix Them), Med Device Online, March 2016. Helman, Saul, et al, Scientific Exchange Definition = Not a Promotional Exchange: How to Provide a Controlled Environment, Navigant Client Publication, May 2015. Farrar, Mark, et al, FDAs New Social Media Draft Guidances: Reason to be Atwitter? Navigant Client Publication, August 2014.Work HistoryOwner, Williams Regulatory Consulting, LLC2022 presentAssociate Director, Guidehouse Consulting 2019 2022 Associate Director, Navigant Consulting 2013 2019 Regulatory Associate, Anson Group 2011 2013Software Quality Assurance Analyst, State of Indiana 2006 2012 Software Quality Assurance Analyst, Deloitte / RCR Technology 2005 2006 Public Assistance Caseworker, State of Indiana 2000 2005 Owner, Williams Used & Rare Books 1998 2005Co-owner, The Bookcellar Used & Rare Books 1992 1998 Memberships and AwardsMember, American Society for Quality (ASQ)Member, Regulatory Affairs Professionals Society (RAPS) Recipient, Navigant Consulting High Performance Award (four-time recipient) Recipient, Max Kade Fellowship, Indiana University Bloomington EducationPostgraduate work in Germanic Studies Indiana University Bloomington Bachelor of Arts degree in Political Science Indiana University Bloomington Certificate in West European Studies Indiana University Bloomington Undergraduate Exchange Student Universitt Hamburg (Germany) Link to writing samples: https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:7eda83ce- 2def-4cb0-8dde-4d7a1cc27a45 |
