Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Highly skilled regulatory affairs and quality assurance professional with extensive experience in combination products, medical devices, and drug/biologic manufacturing. Expertise in regulatory compliance, technical writing, and project management. Strong background in orthopedics, spine, joints, implants, drug therapy delivery, surgical instruments, gastroenterology, cardiology, neurovascular, endovascular, needle/syringe, infusion therapy, and urology.

CORE COMPETENCIES

  • Project Management/Leadership
  • Design Controls
  • Risk Management/FMEA/Hazard Analysis
  • Process Development/Process Controls
  • Operating Procedures/Work Instructions
  • Regulatory Submissions
  • Technical Writing/Protocols/Reports
  • Post-Market Surveillance
  • Change Controls/Life Cycle Management
  • CAPA/Recalls
  • Remediation
  • Quality Systems/Auditing/Gap Analysis
  • Training/Training Materials/Assessments/SOP
  • 21 CFR Parts 4/7/11/210/211/801/803/806/807/810/812/820
  • ISO 9000/ISO 13485/ISO 14971
  • EU MDR 2017/745
  • ISO/ANSI/AAMI Standards
  • MDSAP
  • International Medical Device Regulations (Canada, Australia, Japan, China, Brazil, EMEA, APAC)

SELECTED ACCOMPLISHMENTS

  • Prepared various regulatory strategies and applications for foreign countries for global companies.
  • Conducted gap assessments for medical device manufacturers for product development, remediation, and transition to EU MDR.
  • Developed quality system documentation for compliance with regulations.
  • Led regulatory strategy and CMC submissions for a drug delivery device, including a BLA supplement for a high-profile project at a leading drug/biologics company.
  • Conducted independent reviews of design history files (DHF) for DHF remediation and post-launch compliance with EU MDR and ISO 13485.
  • Led regulatory reporting activities, including design change assessments for product modifications and packaging updates.
  • Directed a remediation team for regulatory compliance updates across multiple top medical device manufacturers.
  • Led global labeling change projects for IFU/PIL updates due to company name changes.
  • Managed regulatory affairs projects involving risk management, CAPA, and regulatory strategy implementation.
  • Conducted regulatory gap analyses for medical device manufacturers preparing for EU MDR certification.
  • Oversaw remediation plans to address 483 observations for a top medical device manufacturer.
  • Served as a regulatory lead in over 200 design meetings for orthopedic implants, surgical instruments, and packaging.
  • Developed and implemented regulatory training programs and compliance initiatives for medical device and combination product manufacturers.
  • Conducted comprehensive CAPA investigations using formal root cause analysis tools to drive corrective and preventive actions.
  • Managed cross-functional regulatory teams supporting global compliance initiatives for medical devices, drug/biologics, and combination products.

PROFESSIONAL EXPERIENCE

  • Quality Solutions Now, Inc. – Consultant (Emmaus, PA) | 01/25 – Present

  • Regulatory Quality Solutions, LLC. – Principal Consultant (Ft Wayne, IN) | 01/22 – Present

    Supporting numerous clients, including:

    • Takeda Pharmaceuticals America, Inc. – Associate Director (Cambridge, MA) | 10/23 – 01/25
    • Zimmer Biomet – Principal Regulatory Affairs Specialist (Warsaw, IN) | 05/24 – 07/24
    • Cerenovus, Ethicon (Johnson & Johnson Subsidiary) – Regulatory Affairs Project Manager (Boston, MA) | 06/22 – 07/23
    • Orthopediatrics – Regulatory Affairs Manager (Warsaw, IN) | 01/22 – 07/22
    • Boston Scientific – Senior Regulatory Affairs Specialist (Marlborough, MA) | 11/20 – 01/22
    • Viant – Senior Regulatory Affairs Specialist (Ft Wayne, IN) | 04/19 – 10/20
    • Conmed Corporation – Regulatory Affairs Specialist (Utica, NY) | 03/17 – 03/19
    • Zimmer Biomet – Regulatory Affairs Specialist (Warsaw, IN) | 12/13 – 03/17

EDUCATION

  • Master of Science, Regulatory and Clinical Affairs – Grace College, Winona Lake, IN | 05/12 – 05/13
  • Bachelor of Science, Business Administration and Management – Grace College, Winona Lake, IN | 01/11 – 05/12
  • Non-Degreed Training:
    • Regulatory Affairs Training Program – Duke University School of Medicine | 04/22 – 07/22
    • Science Teacher Education – Purdue University (Ft Wayne, IN) | 08/07 – 05/09

TRAINING & CERTIFICATIONS

  • Cybersecurity – In Progress (ICS2)
  • Project Management – 2025 (LinkedIn)
  • Live Webinar: Software in Combination Products – Feb 2025 (Biologics Consulting Group)
  • What is Generative AI – Feb 2025 (LinkedIn)
  • Understanding PCCP for AI/ML Medical Devices: A Practical Guide – Mar 2025 (Orthogonal)
  • Data Beyond Trials: Unlocking Real-World Evidence for Regulatory Success – Mar 2025 (MedTech)
  • Future Leaders Session: Mastering Communication – Mar 2025 (Elemed)
  • Winning in the EU: Crafting a Bulletproof Clinical Strategy – Mar 2025 (MedTech Leading Voice)
  • Lunch and Learn: A US FDA Lens on Digital Health Requirements – Sept 2024 (Arnold & Palmer)
  • How to Best Prepare for the FDA QMSR – Oct 2024 (Greenlight Guru)
  • QMS for Medical Device Companies – July 2024 (Emergo)
  • European Union Medical Device Regulation (EU MDR) – June 2024 (Suttons Creek)
  • European Union Medical Device Regulation (EU MDR) – May 2024 (Takeda Pharmaceuticals)
  • eSTAR Webinar – 2024
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications – 2024 (Takeda Pharmaceuticals)
  • Live Q&A with the FDA: Cybersecurity Pre-market Guidance – 2024 (FDA)
  • How to Prepare for and Make the Most Out of Your FDA Pre-Submission – 2024 (Greenlight Guru)
  • 10 Steps to Preparing Your 510(k) Submission (And How to Avoid Common Pitfalls) – 2024 (Greenlight Guru)
  • FDA 510(k) Submission Insider Tips, Tricks, and Timelines from a Former FDA Reviewer – 2024 (Greenlight Guru)
  • Special Controls: What They Are and How to Use Them to Your Advantage – 2024 (Greenlight Guru)
  • Predetermined Change Control Plans for Medical Devices – 2024 (FDA/CDRH)
  • FDA/NIH Regulatory Dos and Don’ts: Tips – 2024 (FDA)
  • Demystifying FDA’s Pre-market Final Guidance – 2024 (Greenlight Guru)
  • The 510(k) and Substantial Equivalence: Why Do So Many Get It Wrong? – 2024 (Greenlight Guru)
  • Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time and Cost to Market – 2024 (Greenlight Guru)
  • Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications 510(k)s with Different Technological Characteristics – 2024 (Greenlight Guru)
  • Considerations for Building Your Own Cloud Device: Regulations, Privacy, and Cybersecurity – 2024 (Greenlight Guru)
  • Developing IEC 62304 Compliant Software: Proven Tips and Best Practices – 2024 (Greenlight Guru)
  • Top Things You Should Know When Developing Software as a Medical Device – 2024 (Greenlight Guru)
  • Key Considerations for SaMD Companies Developing and Commercializing Software as a Medical Device – 2024 (Greenlight Guru)
  • Building Mythconceptions About FDA’s Refuse-to-Accept Policy for Cybersecurity – 2024 (Greenlight Guru)
  • How to Effectively Implement the New ISO 14971-2019 & Maintain Your Current Risk File – 2024 (Greenlight Guru)
  • Risk Management for Medical Devices: An Overview of ISO 14971 & How to Apply a “Risk-Based Approach” to Your QMS Processes
  • FDA Digital Health Updates: What Changed in 2022 and What Should You Expect in 2023? – 2023 (Greenlight Guru)
  • Medical Device Single Audit Program (MDSAP) – 2020
  • New ISO 14971 – 2020
  • ISO 13485:2016 Requirements – 2017
  • Medical Device Single Audit Program (MDSAP) – 2017 (ConMed Corporation)
  • Risk Management for Medical Devices (ISO 14971:2007 & EN ISO 14971:2012)
  • Preparing SaMD for Submission

AFFILIATIONS

Regulatory Affairs Professionals Society (RAPS) – 2021