Regulatory, Quality Assurance, and Compliance Professional


Regulatory, quality assurance, and compliance professional with a demonstrated track record of integrity and excellence. 25+ years of experience in medical device, pharmaceutical, and biologics industries.  

  • 510(k)
  • Risk Management
  • Audits
  • Global Regulatory
  • Master File
  • CE Mark
  • CAPA
  • Project Management
  • Post Market Surveillance
  • Regulatory Strategy
  • Registration
  • Labeling/promotion
  • Design Control
  • Complaint Investigation
  • Due diligence
  • Quality System Implementation
  • Clinical Regulatory/QA
  • CER
  • Traceability
  • GAP Analysis
  • Clinical supplies
  • Agency Interaction
  • Validation




Industry Consultant

Wilmington, NC

Provide cost effective and practical regulatory, quality assurance, clinical, and compliance consulting to the medical device and biologics industry. Serve as a resource to help domestic and international customers focus on their business while keeping in compliance with current regulatory requirements. 


Example Projects:

  • Manage regulatory transition related to new company acquisition and migration to a common Notified Body.
  • Recommend regulatory pathway for marketing in the United States, Canada, and Europe.
  • Create and file 510(k) applications for: mammography diagnostic software, orthopaedic devices, software as medical devices, bone void fillers (HA), personal lubricants/condoms, spinal posterior fixation, diagnostic devices for adjustment of external fixation devices, anterior fixation for spine, 3D printed orthopedic devices, 

suture anchors, cardiac and neurovascular guidewires and catheters, cardiovascular stents, IVD, orthopedic devices with novel materials, dental devices, and sports medicine devices.

  • Master File review and development.
  • Create 21 CFR 820 and ISO 13485 compliant quality system and related technical files.
  • Create and implement processes for tracking clinical supplies and commercial product.
  • Review/create product labeling and make regulatory pathway recommendations.
  • Regulatory diligence regarding new product acquisitions, corporate acquisitions, public financial offerings, and business development arrangements.
  • Present professional training via webinars and white papers on such topics as: post-market surveillance, clinical evaluation reports, FDA refuse to accept guidance, global regulatory strategy, filing 510(k) for software, and essential requirements (ERC).
  • Research and write Clinical Evaluation Reports (CER) across wide range of medical devices.



Associate Director, Global Regulatory Affairs

Director of Regulatory, Chief Compliance Officer

Quality, Regulatory, and Clinical Manager

Baxano Surgical (formerly TranS1), Wilmington, NC

  • Create and manage department budget, global regulatory strategy, and objectives.  
  • Recruit, train, and manage regulatory, quality assurance, and clinical staff of 3 to 15 individuals.  
  • Responsible for complex domestic and international marketing applications for spine/orthopaedics including 9 US 510(k) applications, 2 pre-IDE, 5 CE Mark, 2 Canadian licenses, 3 Indian registrations, 5 Israeli registrations, 3 South Korean registrations, and 3 Australia/New Zealand registrations. Also completed personal import documentation for Japan and initiated approval process for products in Japan.  
  • Prepare and manage technical files and CER for Class I, IIa, IIb, and III products in support of distribution in Europe, Canada, Asia (e.g. Korea, Taiwan, Hong Kong, and India), and Australia. 
  • Select and manage Key Opinion Leaders (KOLs) for regulatory and clinical projects.
  • In cooperation with KOLs, author and publish scientific papers.
  • Research domestic and international regulatory requirements. Provide interpretations of regulatory compliance directives and agency guidance. Apply to relevant compliance and business practices regarding design control, product marketing/distribution, and quality systems.
  • Coordinate audits conducted by external agencies (FDA, Notified Body). Liaison between company and regulatory agencies and legal counsel.
  • Collaborate with Marketing, Sales and Engineering to develop and distribute compliant labeling and marketing materials (spine, bone void fillers, demineralized bone matrix, etc.)
  • Select and manage Notified Body and European Representative.
  • Manage and prepare clinical protocols, reports, publication strategy, and procedures.  
  • Establish and maintain applicable registrations and listings. FDA Official Correspondent.    
  • Establish quality system and lead corporate compliance efforts in conformance with applicable local, state and federal laws and regulations and third party guidelines (i.e. Advamed) inclusive of:  FDA, Quality System Regulations (QSR), ISO 13485, ISO 9001, Canadian Medical Device Regulations, European MDD, HHS-OIG, and FCPA. 
  • Manage, execute or provide quality oversight for verification/validation (V&V) activities for product, process, systems, and software.
  • Regulatory diligence regarding new product acquisitions, corporate acquisitions, public financial offerings, and business development arrangements.
  • Conduct gap analyses, internal audits, vendor audits and lead projects to enhance compliance and efficiency.


2002 -2003

Senior Analyst

Information Technology Consulting Services KMI, a division of PAREXEL International, LLC, Durham, NC (home based)

  • Assigned to DSM Pharmaceuticals, Greenville NC and Wyeth, Andover MA
  • Consulting services to pharmaceutical and medical device clients in support of automated systems for quality assurance, manufacturing, and regulatory activities.  
  • Prepared, reviewed, and executed validation deliverables in support of new and legacy business systems including:  Requirements Specifications, Validation Plans, Risk Assessment, IQ/OQ/PQ Protocols, validation methodologies, data analysis, and Standard Operating Procedures. 
  • Support with respect to GMP and 21CFR Part 11 regulatory compliance.  
  • Interfaced with clients to complete and transition final project deliverables.


1998 - 2002

Quality Systems Manager/Project Manager

Shark Technology, Inc., Raleigh, NC (home based)

  • Assigned to Bayer Corporation’s Biological Products Division
  • Successfully managed Y2K compliance project and SAP R/3 implementation for Quality Assurance function.
  • Selected and managed bi-coastal team to review, research, audit and implement required controlled document revisions and development.  
  • Utilized MS Project and project management skills to manage:  tasks, $3M budget, ($500K under budget) and 10 employees.  
  • Managed, reviewed, and executed validation protocols. Developed and implemented modifications to change control system.  
  • Worked within change management system to implement >200 upgrades to software, equipment, and systems within 8 months.
  • Managed collection of Inspection Characteristics for Quality Module. Quality audited site systems documentation.  
  • Developed and executed disaster recovery plans.  
  • Developed and conducted user training. Supervised team of 15 people. 
  • Developed, implemented, and managed in-house quality system in compliance with ISO 9000 and GMP. Developed and managed training database for 50 employees. 
  • Conducted audits, developed Requirements Specifications, and testing of documentation and products for release to ensure product quality and 21CFR Part 11 compliance.  
  • Coordinated with development teams to incorporate code fixes and enhancements.  

1993 - 1998

Assistant Scientist I/II, Microbiology Laboratory/Analytical Laboratory

Applied Analytical Industries (AAI), Wilmington, NC

  • Trainer, team leader, and analyst for microbial limits, particulate matter, analytical water, LAL, TOC, and microbial speciation tests. Performed analytical tests including atomic absorption, Karl Fischer, dissolution, assay, content uniformity, and acid neutralization on pharmaceutical products, consumer products and nutritional supplements (specifically vitamin products).  Performed all testing in compliance with USP, JP, BP, and EP compendia.  
  • Scheduled, trained, and supervised five analysts. Streamlined receipt process for time-sensitive samples to allow testing within 24 hours from any domestic point of use.
  • Presented technical reports to clients and management.  
  • Audited, authored and implemented standard operating procedures.  
  • Developed and executed validation protocols for methods, processes, instrumentation, and computer systems. Managed water and process validation projects.  
  • GMP reviewer. Building Safety Team Coordinator. Member of Corporate Safety Team, Microbiology Quality Team, Hurricane Response Team, and President’s Club.



Master of Science in Biology (marine)

Master’s Thesis:  The Effects of Malathione on Glutathione s-Transferase in Notropis species.

University of North Carolina at Wilmington, Wilmington, NC

Bachelor of Science in Biology, Minor in Chemistry - cum laude

Southeast Missouri State University, Cape Girardeau, Missouri

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