Consulting business launched to provide cost effective regulatory and quality assurance consulting to the medical device industry. Serve as a resource to help innovative high integrity medical device companies bring their technology to market in the US and in compliance with current regulatory requirements.Example services:•510(k), pre-IDE, IDE, 513(g), CE Mark, and Small Business Qualification Submissions•Virtual Quality Management Representative •Quality Systems Development•Quality Systems Assessments•Post Market Surveillance•Clinical Evaluation Reports (CER)•CAPA•Complaint Investigation•MDR and Vigilance Reporting•Design Controls•Risk Management•Global Regulatory Strategy•Labeling and Promotion•Training•FDA Registration and Listing•Auditing/Management Review•Systems and Process Validation

Responsible for executing global regulatory strategies to secure and maintain market access consistent business objectives, in coordination with key internal stakeholders, and in compliance with all applicable regulatory requirements. Encompasses all domestic and international regulatory procedures, filings and internal/external regulatory professional interactions.• Responsible for complex domestic and international marketing applications including 510(k) applications, IDE/pre-IDE, CE Mark, and Canadian licenses. • Coordinate audits conducted by external agencies (FDA, Notified Body). Liason between company and regulatory agencies and legal counsel.• Collaborate with Marketing, Sales and Engineering to develop and distribute compliant labeling and marketing materials.• Gap analyses, internal audits, vendor audits and lead projects to enhance compliance and efficiency.• Regulatory diligence regarding new product acquisitions, public financial offerings, and business development arrangements.• Develop and maintain post-market surveillance records including risk evaluation, literature search, complication reports, and clinical evaluation reports (CER).

• Responsible for complex domestic and international marketing applications including 510(k) applications, IDE/pre-IDE, CE Mark, and Canadian licenses.• Coordinate audits conducted by external agencies (FDA, Notified Body). Liason between company and regulatory agencies and legal counsel.• Collaborate with Marketing, Sales and Engineering to develop and distribute compliant labeling and marketing materials.• Gap analyses, internal audits, vendor audits and lead projects to enhance compliance and efficiency.• Regulatory diligence regarding new product acquisitions, public financial offerings, and business development arrangements.• Create and manage department budget, global regulatory strategy, and objectives. • Recruit, train, and manage regulatory, quality assurance, and clinical staff of 3 to 10 individuals.• Select and manage Key Opinion Leaders (KOLs) for regulatory and clinical projects.• Manage and prepare clinical protocols/reports, clinical evaluation reports (CER), publication strategy, and procedures.

• Responsible for complex domestic and international marketing applications including 510(k) applications, IDE/pre-IDE, CE Mark, and Canadian licenses.• Coordinate audits conducted by external agencies (FDA, Notified Body). Liason between company and regulatory agencies and legal counsel.• Collaborate with Marketing, Sales and Engineering to develop and distribute compliant labeling and marketing materials.• Gap analyses, internal audits, vendor audits and lead projects to enhance compliance and efficiency.• 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: Quality System Regulations (QSR), ISO 13485, ISO 9001, Canadian Medical Device Regulations, European MDD, and Foreign Corrupt Practices Act (FCPA).

• 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 §11 regulatory compliance. • Interfaced with clients to complete and transition final project deliverables.

Manage company quality system. Provide consulting services to pharmaceutical clients in relation to information systems and processes for quality. Consulting areas: equipment and process validation, 21 CFR Part 11, project management, process improvement, budget, SAP, ERP, PLC, gap analysis.• Selected and managed bi-coastal team to review, research, audit and implement required controlled document and systems implementation. • Utilized MS Project and project management skills to manage: tasks, $3M budget, ($500K under budget) and employees. • Developed and implemented modifications to change control system. Managed, reviewed, and executed validation protocols to implement >100 upgrades in < 8 months.• Developed and executed disaster recovery plans. • Developed, implemented, and managed in-house quality system in compliance with ISO 9000 and GMP.

• Supported pharmaceutical clients as an independent consultant. • Audited existing Quality Assurance documentation and provided GAP analysis and updates to meet regulatory requirements. • Developed Standard Operating Procedures (SOP) in support of facility validation.

Initial work in wet chemistry lab doing dissolution, content uniformity, Karl Fischer, and GMP review. Moved to Microbiology lab where I served as team leader, technical liason to sales, and trainer. Test areas: process and equipment validation, water system validation, method development, LAL, particulates analysis, sterility, filtration methods, Gram stain, identification via Vitek and GC, JP, EP, BP, and USP. Served on quality, safety, and hurricane preparedness teams. President's Club.