- Experienced in building internal audit and supplier audit programs. Also, in conducting internal, supplier, corporate, and due diligence audits both domestically and internationally.
- Conducted mock FDA inspections at newly acquired facilities and at a corporate facility that received a warning letter.
- Acted as Front Room Lead, Facilitator and Subject Matter Expert for FDA inspections.
- Successfully led FDA Audit Preparation activities including front room/back room preparation, audit preparedness planning and employee/regulator interface training.
- Successfully managed notified body audits, UL inspections, and FDA inspections.
- Prepared responses to regulatory agency communications including the preparation of data for FDA 483 response.
- Led team of regulatory and quality professionals in quality and regulatory strategic planning
- Managed QA/RA professionals responsible for day-to-day quality, compliance and submission activities
- Conducted Proactive PostMarket Surveillance including the review of warning letters, 510ks, Correction and Removals, and adverse events.
- Project leader of successful site implementation of revised medical device Directive 2207/47/EC.
- Skilled at performing MDD, CMDR, QSR Training for employees.
- Managed Correction and Removals and formulated Part 806, FSCA, FSN reports.
- Developed regulatory strategies in Quality System remediation for quality systems including containment activities, remediation planning, risk assessments, and managing overall remediation projects.
- Conducted audits of quality system records as part of remediation activities. Records reviewed included: supplier and part qualification records, supplier master files audit records, receiving inspection records, management review, quality subsystem review, nonconformance records, and CAPA records.
- Conducted audits of Corrections and Removals files for compliance to 21 CFR Part 806.10 and 806.20. Performed subsequent remediation of Correction and Removal files.
- Provided expert guidance and direction to teams responsible for CAPA remediation and established internal awareness of FDA expectations for CAPA programs.
- Led QMS and Regulatory activities in transferring manufacturing operations across sites and to contract manufacturers.
- Maintained and interpreted existing and emerging regulations, standards, or guidance documents.
- Managed the complaint investigation unit, reviewed complaint records, and filed adverse event reports with appropriate regulatory agencies.
- Identified budget needs, established budget and maintained Opex and capital expenses to budget.
- Performed Quality System gap assessments to regulatory standards and building a QMS.
- Responsible for the management of the Document control, Change Management, and calibrations systems.
- Experienced in the creation of a document control infrastructure and in the creation, writing, and maintenance of SOP’s.
- Managed the assessment, acquisition, and deployment of new electronic complaint and CAPA data management systems.
- Built systems for assessing changes to domestic and international submissions, assessed gaps and developed/implemented plans to address gaps.
- Established system for creating and maintaining MDD technical files
- Developed STED templates for international regulatory submissions
- Provided regulatory strategies to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulated and implemented regulatory affairs policies and procedures to optimize regulatory compliance.
- Coordinated, prepared, and reviewed data for domestic (510(k) and international regulatory.
- Reviewed device promotional materials, labeling, device history records, specification sheets, or test methods for compliance with applicable regulations and policies.
Premier Regulatory Consultants, LLC, 5229 Woodruff St, Dover, Ohio 44622
President, November 2013- Present.
Regulatory Compliance/Affairs and Quality Systems Consulting including:
- Auditing of QMS records during remediation: CAPA’s, Management Review, Receiving Inspection, Complaints, Deviations, Defect Investigations, and Correction and Removal records.
- Managed and drove the timely completion of CAPA’s relating to FDA 483 observations in Production and Process Control and Purchasing Controls.
- Conducted CAPA effectiveness checks in Corrections and Removals for Third Party Certification audits.
- Conducted gap assessment and remediated client Corrections and Removal files.
- Acted as Final QC Auditor of QMS records during FDA 483 inspection and Third Party Certification Audits.
- Revised PostMarket (Corrections and Removals) standard operating procedures and work instructions.
- Lead Assessor for Quality System Audits for 21 CFR Part 820, 806, 803, ISO 13485, CMDCAS, and JPAL requirements for global clients.
- Conducted FDA prep activities and FDA Mock inspection for client’s international site.
- Wrote Quality Management System procedures for a startup medical device company.
Zimmer Surgical, 200 West Ohio Avenue, Dover, Ohio 44622
Regulatory Compliance Manager, July 1985 – November 2013
- Manager of Regulatory Affairs and Compliance for global divisions. Responsible for assuring site compliance with domestic and international standards. Successfully managed Regulatory Affairs/Compliance functions, Internal/Supplier Audit programs, and PostMarket Surveillance activities including Complaint Handling and Adverse Event Reporting, Corrections and Removals, Proactive PostMarket Surveillance activities, Document Control and the Change Management Process. Played a key role in manufacturing transfer activities to contract manufacturers and internal facilities. Conducted Due Diligence Audits. Responsible for the development of Quality System Integration Plans for acquisitions. Responsible for the development and maintenance of Opex and capital budgets. Acted in a lead role for the execution of Quality Systems Remediation and successful subsequent FDA site inspection.
Zimmer Surgical, 200 West Ohio Avenue, Dover, Ohio 44622
- Responsible for the Quality Assurance department including the supervision of numerous Product Quality Inspectors. Responsibilities including oversight of Incoming, In- process, and finished device acceptance activities. Performed DHR review and final product release. Responsible for the development and management of the gauge calibration program. Acted as Quality Assurance subject matter expert during regulatory agency inspections. Responsible for the development and maintenance of Opex and capital budgets. Promoted to Regulatory Manager.
Bachelor of Arts Degree in Business Management
Stark State College
Associate’s Degree in Medical Laboratory Technology
Certified ISO 13485 Lead Auditor
Internal Auditor, ASQ
ISO 13485 Lead Assessor Stat-a-Matrix
Lean/Six Sigma Black Belt Training, Kent State University
Quality System Regulation Training, AAMI