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Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator and over 12 years of industrial experience as a medical device, biologic, pharmaceutical, food, and tobacco products industry quality assurance consultant, regulatory compliance specialist, and ASQ certified quality biomedical auditor. As such, Expert is familiar with all types of FDA and internationally regulated products and operations.

His educational background includes two BS degrees in Chemistry and Metallurgical Engineering from the University of Notre Dame, an MBA in International Business from Indiana University, and a MS in Regulatory Affairs for Drugs, Biologics, and Medical Devices with a concentration in Regulatory Compliance from Northeastern University. Currently, Expert is pursuing a Ph.D. in Business Administration with a concentration in International Business from South University. As such, not only does Expert have vast internal working knowledge of FDA operations, but he also understands the need to balance industry business goals against external regulations, the linkages between the various quality system and clinical subsystems, and the struggles with quality, cultural, and business barriers to achieve sound quality systems.

Expert has inspected, investigated, and audited all types of US and foreign food, cosmetic, drug, biologic, medical device, combination product, and clinical facilities, but has also performed various quality assurance and regulatory compliance operations for various FDA and international governmental bodies’ regulated industries, such as monitoring and maintaining product and quality system failure investigations, non-conformances, complaints/ MDRs, and CAPAs, reconciling and analyzing numerous quality system data, writing and revising numerous top and mid-level written procedures, training various governmental and industry personnel in the areas of medical device quality, quality system, design control, and documentation and change control, and informing management and staff of current FDA and international enforcement policies.

His expertise is primarily in medical device and combination product quality assurance and regulatory compliance, and has vast knowledge utilizing U.S., European Union, Canadian, Australian, Brazilian, Japanese, Chinese, and other international medical device and combination product quality system, regulatory, legal, and clinical laws, regulations, standards, and guidelines. However, he is also familiar with and knows the similarities and differences between US food, human and animal pharmaceutical, cosmetic, biologic, tissue, clinical, and tobacco product laws, regulations, guidelines, and operations as well.

Expert is a self-starter with good written and oral communications skills and has a strong history and a proven and successful track record of accomplishment through leading and/or working with teams. Expert strives for continuous improvement, consistency in quality assurance and regulatory compliance with reduced waste while auditing, consulting, and contracting medical device, biologic, and pharmaceutical facilities. Expert has participated in multiple projects to problem solve and has participated in and/or set up quality audit teams and wrote team reports while in the governmental and industrial capacities. In all projects, Expert has demonstrated hands on expertise in various regulatory compliance and quality assurance activities. As such, these expert skills and knowledge have resulted in increased quality, regulatory, legal, business, and operating integrity for not only the management and staff Expert has assisted, but also for the greater protection of the U.S. and international consumers as well.

In addition, Expert is not the typical regulatory compliance and quality assurance expert. Not only does Expert understand the inner workings of the FDA and regulated industries and staff, but also understands international business and management operations too. Expert’s Myers-Briggs profile is also non-typical as well (i.e. an ‘off-the-chart’ ENFP profile, which is in the direct opposition to many quality and regulatory personnel). Unlike many people, Expert excels in public speaking and mentoring/ coaching others to succeed. Also, due to his strong “highly moral and ethical” beliefs, Expert is not afraid to challenge and educate unethical and immoral personnel so that they may understand the legal and regulatory consequences of their questionable and biased actions. These additional strengths have given Expert the necessary skills to multi-task, work as a team player, and be a leader, coach, and mentor while understanding the mechanisms of quality systems and the subsystem linkages balanced with the internal and external business constraints of clients. Therefore, for over 34 years, Expert has successfully assisted numerous US and foreign companies to achieve quality and regulatory compliance, especially in the medical device and combination product arenas.

ASQ certified (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems. Expert's career has been concentrating on US/ EU/ Canadian/ Australian/ Brazilian/ Japanese/ Chinese medical device auditing, investigating, compliance, and regulatory (except for preparing regulatory submissions). He is not a quality engineer or a regulatory affairs specialist; nor has he set up process validations, design and process specifications, nor have written any regulatory submissions (i.e. 510(k)'s, PMA's, technical files, or design dossiers). However, he is familiar with quality engineering and regulatory affairs operations, processes, and activities and has successfully performed process validations in accordance to validation protocols, inspected, tested, and measured products in accordance to master record specifications, assisted SMEs with 510(k) reviews and replies, and audited and reviewed thousands of written procedures, quality records, quality system records, regulatory submissions, process validations, and design studies to see if they conform to external laws, directives, regulations, standards, and guidance. Expert has seen all types of quality system and clinical operations, conducted gap analyses/ data reconciliations, and has given training and guidance to both governmental and industry personnel in these and other pharmaceutical, biologic, and medical device areas for over 34 years. He has also performed various hands-on non-technical quality assurance and regulatory compliance operations, such as preparing/ revising written procedures, preparing 21 CFR 803 baseline reports, conducting out of specification investigations, performing data reconciliations, and monitoring and maintaining complaints, non-conformances and CAPA's. Expert is willing to take assignments anywhere worldwide and travel 100% (including internationally).

34 years of professional experience as a level II certified international medical device investigator in the US government or as a contract quality assurance consultant and regulatory compliance specialist in the medical device industry, Expert has a strong history and a proven track record of leading or working with the team in quality auditing of domestic and international class I/III medical device products, facilities and operations. He strives for continuous improvement, and consistent quality assurance with reduced waste while auditing, consulting, and contracting medical device facilities. This includes auditing, reviewing, and critiquing all validation/ verification, protocol documentation, set up testing, build fixtures, define and setup quality assurance programs, and train personal (in-house, and/or contractors, local and offshore) while insuring a quality FDA QSR and/or ISO 9000-9003 certified build. Expert has participated in multiple projects to problem solve while working in the government arena and as a medical device consultant. He has participated in and/or set up quality audit teams and wrote team reports while in the government or as a consultant; audited, reviewed, and critiqued FMEA's, data and ongoing design considerations. In all audit and consulting projects, he has demonstrated hands on expertise. These skills have resulted in increased quality and operating integrity.

HIGHLIGHTS OF QUALIFICATIONS
• Medical Device Compliance
• Results Oriented
• Problem Resolution
• Failure Modes & Effects Analysis
• Strong Negotiation Skills
• Strategic Planning
• Excellent Communication Skills
• Team Player and Leader
• Project Management

SELECTED ACHIEVEMENTS
Quality Assurance Consultant, Regulatory Compliance Specialist, ASQ certified Quality Biomedical Auditor (QBA), and FSPCA certified Preventive Controls Qualified Individuals (PCQI) (for past 12+ years, since 2006) for various food, tobacco product, biologic, pharmaceutical, and medical device manufacturers (including combination product manufacturers), including:
• Conducts first party (internal), second party (supplier), and 3rd party (mock, specialized, trace-back, and process) audits, investigations, and gap analyses of quality system and regulatory operations using FDA and various international laws, regulations, directives, standards, and guidance, including 21 CFR 3 & 4 (combination product), 21 CFR 11 (electronic records and signatures), 21 CFR 50-58 & 812-814 (BIMO), 21 CFR 110 (food GMP), 21 CFR 210/211 (drug cGMP), 21 CFR 604 (biologic GMP), 21 CFR 803 (MDR), 21 CFR 806 (CAR), 21 CFR 807 (registration and listing), 21 CFR 809 (IVD), 21 CFR 820 (QSR), 21 CFR 821 (Tracking), EU Active Implant Device Directive (AIDD, EU In-Vitro Diagnostic Directive (IVDD), EU Medical Devices Directive (MDD), EU Medical Device Regulation (MDR), Canadian SOR.98-282, Japanese JQMS MHLW Ordinance #169, Brazilian Resolution No 59, Chinese SFDA GMP for Medical Device #833, and Australian Therapeutic Goods (Medical Devices) Regulations # 236, and various US and international standards and guidance documents, including ISO 13485 & ISO 14971, EU’s MEDDEV 2.12-1, and FDA’s IOM, QSIT, RPM, and compliance programs (such C/Ps 7348.808, 7348.811, 7383.001, and 7382.845).
• Provides regulatory, quality, and technical expertise to top management.
• Directs mock/internal/external FDA QSR, product, and process audits and investigations of manufacturing facilities, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, and tissue realms.
• Performs gap analysis and initial qualification of GLP facilities for USA Sponsor-Monitor of investigation device exemption (IDE) medical device using FDA laws and regulations.
• Facilitates training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/research and development (R&D), and production departments.
• Analyzes business, legal, quality, sterilization, and nonconformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.
• Performs various reconciliation activities, including corrective action planning, procedural reviews, auditing, procedural revisions, and training.
• Serves as resource for customized marketing research in industries or areas related to FDA medical device quality systems, governmental registration process, international business, and QSR/cGMP.
• Performs and/or assists in FDA Warning Letter and Consent Decree reconciliations, including food sanitation, drug cGMP, and medical device quality system (such as design control, change management, and CAPA system) corrections.
• Provides expert quality and regulatory expertise to various industry and legal personnel pertaining to adulterated/ misbranded/ non-conforming medical devices and non-compliant quality systems.
• Performs and/or assists in various front-room and back room inspection readiness activities prior to, during, and after FDA medical device inspections at U.S. and foreign medical device facilities.
• Acts as an FDA medical device quality assurance and regulatory compliance expert in various legal cases.
• Oversees, monitors, and maintains product and quality system failure investigations, nonconformances, complaints/medical device reports, and Corrective Action/Preventive Action (CAPA) programs.
• Reconciles and analyzes numerous quality system procedures and data.
• Writes and revises top- and mid-level written procedures.
• Trains various governmental and industry personnel in various areas of medical device quality, quality system, quality auditing, design control, CAPA system, and documentation and change control.
• Has internal working of FDA field and headquarter offices (including ORA and CDRH).
• Performs process validation activities in accordance to approved process validation protocols.
• Performs inspection, testing, and measurement activities on received, in-process, and finished products in accordance to approved master records and quality system requirements.

Analyst/ Level II certified International Medical Device Investigator for the FDA (for 21+ years up to 2006), including:
• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry.
• Performed full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices located throughout Asia, Canada, and Europe.
• Advised industry, state, and local officials and consumers on enforcement policies.
• Led training sessions on inspection and investigation techniques and other related topics.
• Served as subject matter expert on all provisions of the Federal Food, Drug, and Cosmetic Act.
• Conducted all types of independent inspections and investigations with minor or no supervisory guidance. The knowledge and experience to conduct all types of inspections and investigations meeting FDA requirements. These inspections included complex, unusual and intricate manufacturing processes, dealing with uncooperative firm managers and personnel. Successfully collaborated with other agencies including local, state, and federal to meet FDA guidelines.
• Collaborated and managed all types of medical device inspections and investigations, including inspections conducted the FDA. Participated in the Agency’s Foreign Inspection Program, concentrating in the medical device area.
• Managed food sanitation, drug, cosmetic and medical device inspections and various investigations including complaint follow-ups, recall audit checks, and undercover buys. Responsible for independently conducting all import operations at this resident post with no supervisory guidance.
• Trained various local, state and federal investigators in food sanitation, medical device, biologic and drug inspection techniques and in import operations. Worked independently and have become familiar computer operations. Involved in classroom and OJT training of peers and lower level district employees in the medical device area. Mentored lower level employees in the medical device area.
• Recommended to regional and district management officials as to whether or not a firm / individual involved in the production, control, and testing of medical devices and diagnostic products complies regarding Current Good Manufacturing Practices (CGMP). Analyzed reports of inspections and investigations for violations and determine the sufficiency of evidence.
• Managed the review of previously approved products to determine whether they should continue to be permitted in light of current scientific safety data. Coordinated the collection of data, managed a scientific review, and recommended a course of action, such as product guideline performance test standards and product recalls.
• Developed and implemented formal training programs for Agency personnel and provided technical expertise to industry representatives. Conducted on-the job training for Consumer Safety Officers and others and other training for investigators, supervisors, compliance officers, district personnel, and industry regarding technical and scientific matters, inspection / investigation issues, policies, and laws affecting the medical device program.

SKILLS
• Audit, review, and critique most lean related quality system, manufacturing, testing, and design technologies.
• Perform regulatory compliance data reconciliations and documentation and change control and FDA classification, registration, and listing operations.
• Skilled in quality and business concepts, including quality systems and international business management.
• Revise, prepare, audit, review and critique QA (quality assurance) and QC (quality control) programs and documentation to ensure quality production.
• Provide QA/ QC, manufacturing. and test support for manufacturing, floor, and contract vendor production lines.
• Provide information and support for ongoing product design and new product design review boards.
• Audit, review and critique all quality system procedures, records, protocols, reports, and other quality and regulatory documentation [including QMs (quality manuals), SOPs (Standard Operating Procedures), WIs (Work Instructions), and master quality procedure system forms and templates] associated with the QMS (quality management system), management controls, design controls, purchasing controls, material controls, equipment controls, the CAPA system, production and process controls, document, design, and process controls and change management activities, and various process validation activities [including prospective validation IQ (installation qualification), OQ (operation qualification), PQ (process performance qualification), and PPQ (product performance qualification) areas, and concurrent and retrospective related validation protocols, reports, and other documentation].
• Audit, review and critique all QC and manufacturing related protocols and documentation.
• Audit, review and critique Risk Management program and deliverables [such as FME(C)A’s (failure mode, effects, (and criticality) analyses), FTA’s (fault tree analyses), etc.].
• Audit, review and critique manufacturing program procedures, sampling, and processes.
• Participate and represent Regulatory Compliance in various Design, Quality, Regulatory, and Manufacturing meetings (such as pertaining to post-market assessment and surveillance activities, material reviews, nonconforming product and process identifications, evaluations, dispositions, control, corrections, corrective actions, and/or preventive actions).
• Knowledgeable in various domestic and international laws, regulations, directives, standards, and guidance (including FDA, Health Canada, EU, Australian, Brazilian, Japanese, and Chinese medical device and combination product requirements).
• Train and Qualify quality, regulatory, operational/ production, and administrative personnel related to the design, manufacturing and test processes and other quality system requirements.
• Work with ISO/EU/CE Mark, FDA, Health Canada, and other public health and industry personnel, documentation, systems, operations, and requirements.
• Revise, prepare, audit, review and critique Multi-level SOP, BOM (bill of material), and ECO (engineering change order) process instructions and records.
• Audit, review and critique SPC (statistical process control) and QC/QA related protocol and documentation.
• Skilled in New Product Introduction (NPI) and CE mark certification processes.
• Audit, review and critique validation SOPs and policies according to cGMPs (current good manufacturing processes) for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, chemical, etc.).
• Audit, review and critique large and small subsidiaries and vendors for set-up and transfer of products to headquarters and vendor sites.
• Audit, review and critique schematics, blueprints and build instructions for various medical devices, including in-vitro diagnostics, orthopedic, electrical and mechanical devices.
• Audit, review and critique purchasing control records and operations and software and hardware validations.
• Audit, review and critique Failure mode effect analysis of product design specifications and documentation.
• Monitor, maintain, audit, review and critique Corrective action and process document processes.
• Audit, review and critique Design review FME(C)As, FTAs, and other risk analysis tools and corresponding risk management activities, processes, and documentation for new and revised product design analyses.
• Audit all major inspection, measurement, and test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.).
• Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.).

REGULATORY EXPERTISE
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-Mechanical Medical Devices- Durable, Electronics, Implantables, IVDs (In-Vitro Diagnostics), Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, GMP, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management), EU Active Implantable Medical Device Directive (AIMD) / EU In-vitro Diagnostic Directive/ EU Medical Device Directive (MDD)/ EU Medical Device Regulation (MDR), Regulatory Compliance, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, and Working Knowledge of FDA Field and HQ Staff, Websites, Databases, Procedures, and Operations.

TECHNICAL QUALIFICATIONS AND ADDITIONAL TRAINING
Familiar with the working of various FDA medical device databases, MAC/PC Applications, MS Office applications (such as MS Word, Excel, PowerPoint, Outlook, and Visio), and various medical device/ industry automated systems (such as Verse, ETQ, TrackWise, and Device Events). Additional training includes: QSIT (Quality System Inspection Technique) Basics, Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/ Devices, and Orientation to International Inspections.


*Note: Many more employment positions- list available upon request.