*

WILLIAM (BILL) JACKSON, MBA

Broomfield, CO ***23 USA • 510-***-**** • ad1nh3@r.postjobfree.com

Accomplished Management Executive (Medical, Scientific, Regulatory, Quality, Clinical, Compliance) with exceptional team-building skills; well-prepared to excel as Senior VP, VP, or Senior Consultant (Regulatory/Clinical Affairs/Compliance) to Life Science Industry STRATEGY DESIGN & EXECUTION • REGULATORY (US AND ROW) • CLINICAL AFFAIRS (US AND ROW)

•COMPLIANCE (US AND ROW) •TEAM-BUILDING

P R O F I L E

• Substantial background in life science industry, cooperative relationships with notified bodies and key FDA personnel, investigators, institutions, SABs, KOLs and recognized expert on all aspects of clinical trial strategy, compliance activities (AIMD/MDD, MDR, IVDR, EMEA, FDA Design Control, Document Control, UDI, Registration/Listing, Importing/Exporting, Recalls/Vigilance, MEDDEV 2.12/1 (FSCA, MIR, FSN, PSR, PMS) Risk Management, MEDSUN, PAS, FAERS and regulatory strategy, project management (US and ROW)

• Excel at driving clinical, compliance, and regulatory initiatives, reporting to C-level management, remediating risks, delivering training, and building unified, influential, and purposeful clinical, compliance & regulatory teams

• Four Times as Vice President of Regulatory, Clinical, and Compliance, functioning as Management Representative, Compliance Representative, QA, and RA

• Three Times as President of Consulting Firm WF Jackson Associates, Limited

• Former Director of Clinical/Regulatory Affairs, Clinical Affairs Manager (US and EU), Clinical Program Manager (Field Clinical Engineer), Research Assistant, Sales Representative (Pharmaceutical), Surgical Assistant, Autopsy Assistant, and ER Orderly

• Additional Experience in ERs, ORs, and Pathology Laboratories

• Lecturer to Graduate BIOMEDICAL Engineers and Undergraduate Pre-Medical Majors for 7+ Years

• 40+ years’ experience with Class I, II, IIa, IIb, III, and IV (Canada) devices

(electromechanical/software/allograft/biologics/medicinal products/capital equipment/ELISA/ HPLC/ reagents/consumables

• 40+ years’ experience in FDA/ROW compliance, project management, clinical research, CRO management, CE marking, GCP/GLP/GVP/GDPR/HIPPA/RoHS/WEEE, and Risk Management

• 40+ years’ experience with FDA requirements, four years experience in IVDR/MDR/UDI

• 25+ years’ experience in Compliance/DME/HIPPA/GDPR/RoHS/WEEE as CCO/Consultant

• Conducted 40+ Compliance Audits/Gap Assessments to OSHA, ISO 14000, ISO 45001, ISO/IEC TS 17021, PS 9000, and EU Good Documentation Practices (GDP) for Medicinal Products for Human Use

• Chosen by leading heart valve manufacturers (SJM, Medtronic, Shiley) for initial writing of active implantable medical devices (AIMD) and medical devices (MDD) via IAPM and European Commission

• Orchestrated, prepared, and directed (project management) submissions/clinical data to over one hundred countries spanning European Economic Area (EU and EFTA), Middle East/Africa, Pan-Pacific countries, and the Americas

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• SME covering Australia, Brazil-ANVISA, Canada- Health Canada, China- NMPA, European Union- AIMD/EMA/IVD/IVDR/MDR, India- CDSCO, Japan, Mexico- COFEPRIS, Republic of Georgia- FDA Saudi Arabia-FDA, and United States-FDA

• Organized with Teams Clinical Trials in Australia, Brazil, Canada, China, the European Union, the European Free Trade Association, India, Japan, the Republic of Georgia, Schengen Countries, and the USA

• SME/Lead Auditor for GxP (GMP/GCP/GLP/GVP): GMP, Facility GMP, BIMO, Mock, Packaging/Labeling/eIFU, Chemical, RoHS, WEEE, MDSAP, Quality, ISO, ISO 22442, Clinical Quality, Internal

(FDA, CE, MDD, JPAL, HC, TGA, ANVISA), 21 CFR, ICH, Vendor, Certification, Surveillance, INMETRO, Compliance, QSIT, CMDCAS, MRS (UK), Scope, US Companies and OUS Companies Before FDA, Clinical Trial and Supplier (Schedule, Preparation, Conduct, Report, Action Items) Audits/Gap Assessments

• SME on ALL Compliance activities (ICH/GCP/GLP. PAS, PRC, GVP/GDPR/HIPPA/RoHS/WEEE/, IEC 62304, IEC/TR 80002-1, IEC 62366, IEC 60601-1, ISO 19011, ISO 13485-DESIGN CONTROL, ISO 22442, ISO 14155, ISO 14971-RISK MANAGEMENT, MDSAP, IVDR, MDR), CLIA, CAP, UDI, new Clinical requirements

(CERs/PMS/PMCFs/ISO 14155/MEDDEV 2.7.1 Rev 4)), MEDDEV 2.12/1 for EU and Compliance activities in China, Japan, the US, Canada, and Australia

• SME on FDA Submissions (HDE-6+, EFS (FIH)-12+, IDE/INDs-65+, 510(k)-310+, PMA-4, De Novo-6+, 6+- BLAs, PMAS-105+, Combination Devices-10+)-Trained by the FDA on 510(k’s), Brought TUV SUD (PS) First Third-Party Reviewer for Premarket Notifications and FDA Regulations

• SME30+ Years’ experience with software in medical devices and digital therapeutics, with over 50+ 510(k’s) with software submitted/cleared

• SME SaMD

• SME on Business Process Improvements (BPI): Including Six Sigma, DMAIC, 5 Whys, and PDCA

• Certified/Trained by bsi on MDSAP Covering ISO 13485:2016 plus Regulatory Requirements for FDA, TGA, HC, ANVISA, AND MHLW (Certificate Number: 889****-******)

• Trained by NSF on China-Global Medical Device Regulatory Requirements including ACPEIP

• SME on AIMDs, including Cardiac pacemakers, SCS, DBS, and other stimulators for pain and foot drop

• Key Member (Stakeholder) on Submissions and Development Teams for Multiple Complex Medical Device Systems (Combination/Electro/Mechanical/Software/Hardware/Sterilized/Implantable)

• ASTM Committee Member, A01-Steel, Stainless Steel and Related Alloys plus F04-Medical and Surgical Materials and Devices

• Retained relevant contacts with best-in-class CROs and with all leading NBs/CAs as well as pertinent FDA personnel at CDRH/CDER/CBER and Office of Product Evaluation and Quality OPEQ P R O F E S S I O N A L E X P E R I E N C E

WF Jackson Associates, Limited (WFJA), Broomfield, CO, 2018 to Present Senior Consultant/President

All Bullet Points are from the Spring of 2018 to the Present

• CMC (CGMP) Gap Assessment/BPI of Allograft before FDA BLA Submission with Four Consultants, Lead Auditor-Complete

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• Developed an MDR/IVDR Gap Assessment/BPI tool for gaps including CER/PMS/PMCF (Process, Templates, Plans, Budgets, Reports) to the new MDR/IVDR- Complete

• Four Packaging/Labeling Audits to FDA CGMP/ICH (DEA Products for Clinical Investigation) and PS-9000 for Secondary Packaging for FDA Medicinal Products, all OUS with input from four different suppliers, Lead Auditor- Complete

• Commenced FDA De Novo Classification (Combination Product) Request-On Hold, waiting for additional materials

• Lead MDSAP Gap Assessment/BPI (AIMD, MDD) including CER/PMS/PMCF (Class III, Bovine), as Project Manager/Lead Auditor-Complete

• Lead MDSAP Gap Assessment/BPI (MDD), including CER/PMS/PMCF (Class IIb), as Project Manager/Lead Auditor- Complete

• Managed a Team (CRO, Statistician, Writer, Monitor, Core Lab, DSMB, and KOLs) Premarket Clinical (CER, PMS, PMCFs) /Regulatory Analysis Report- Combination Device- Complete

• Orchestrated FDA 510(k) Review with Team, including CER/PMS/PMCF of Class II, also covered MDR/UDI- Complete

• Led FDA CGMP and ISO 22442-Audit to Parts 1, 2, 3, and 4 as Project Manager /Lead Auditor for two different companies (bovine and porcine) usage in CV products- Complete

• Oversaw FDA PMA Supplement-Implantable (AIMD) with PMS with Team Members in Europe and the US- Complete

• Lead MDSAP Gap Assessment/BPI including CER/PMS/PMCF IVD, Project Manager/Lead Auditor- Complete

• Consulting to Italian Based Company (Startup) (Two PMA Devices (Animal Tissue Component) for Breast, Liver and Lung Cancers via Unique Delivery System) as Senior Consultant/VP RA/Clinical/Compliance regarding Medical/Scientific/Regulatory/Clinical (CERs/PMS/PMCFs-Processes, Plans, Templates, Checklists, Reports, Budgets)/FIH/Compliance-Design Control/Risk/EMEA- Waiting on Company to obtain funding, on hold

• Oversaw/Authored/Project Manager of Regulatory/Clinical (CERs, PMS, PMCFs)/Compliance Due Diligence Report OUS (Russian) Investor on Israeli Device (MDD) Company (Startup) for 510(k) Submission- Complete

• Orchestrated Gap Assessment/BPI (AIMD) covering FDA QMS, ISO 13485: 2016, MDR/UDI and Japan

(PMDA)- Complete

• Produced/Presented MDR/UDI Training (Eight Hours) to Device (Dental) Company (Executive Team, S/M, Engineering, Quality, Purchasing, Regulatory, Clinical)- Complete

• Wrote Two Regulatory Strategy Documents for two different devices AIMD and IVD companies (Startup) covering FDA, 510(k), ISO 13485, and MDR/IVDR, including UDI, PMCF Processes, Vigilance, Plans, Templates, and Budgets- Complete

• Repeat as Lead MDSAP Gap Assessment/BPI (MDD) including CER/PMS/PMCF (Class IIb), as Project Manager/Lead Auditor for Ophthalmic Laser Company- Complete

• Advised four companies (Startups) in Ireland as to the appropriate steps to obtain MDR/UDI Registration and for FDA Clearance, Exempt or 510(k), - Complete

• Consultant/SME utilizing Smartsheet (Devices, Biologics, DME, Medicare, Payer, GDPR/HIPPA/RoHS/WEEE BPI) to PwC, PLS Clinical & Safety- Complete

• CER to MEDDEV 2.7.1 According to Rev 4, completed within seven days, CV/Cardiology Company- Complete

• Gap Assessment to 21 CFR Part 212 and FDA Compliance Policy Guide, Radioactive Drugs,7356.002P- Complete

• Gap Assessment to 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies- Complete

• Three Regulatory Pathways for IVD Company (Startup) for China (PRC), EU (IVDR), and US (RUO, CLIA, Exempt 510k, 510k, De Novo/510k, BLA, PMA, IND/NDA, Combination Product), 50+ page document- Complete

• Sourced/directed/managed a large animal facility for implant study in the US for preliminary implant study for non-GLP Study, UCSF -Complete

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• Consultant to Indian Company (Startup) regarding FDA’s EUA for COVID-19, Temperature Monitor and Mouth Swabs- Complete

• Four Regulatory Pathways for Device Company (Startup) (UK) for FDA Class III and EU (MDR) Class IIb or III, 30-page document: Synopsis, Timeline, Estimated Costs, and Four Separate Pathways- Complete

• Provided Training/Consulting to Combination Product-CV (Startup) AIMD catheter in Sweden covering ISO 22442, API-GMP, Response/CAPA to Notified Body- Complete

• Consultant for PPE N95 Mask covering: EUA, NIOSH, Facilities-21 CFR Part 820, and ISO 13485:2016, and FDA Submission Strategy 510(k)- Complete

• Consultant to Sanitizer Company (Startup) covering EUA and FDA- Complete

• Completed Answers to FIH Study in the Republic of Georgia, 30+ questions within the two-week timeline, over 500 pages of documents- Complete

• Remote Training for Combination Company (10 employees) Emphasis on ISO 22442-1, 2, 3, and 4, Three Days- Complete

• Remote Training for Combination Company (10 employees) Emphasis on ICH Q7 GMP and APIs, Two Days- Complete

• SME on SaMD

• SME on Combination Products

• SME on Covid-19 Products (Sanitizers, Face Masks, Temperature Monitor and Mouth Swabs, IVD Combination Products/Vaccine/IVD Devices (Software/Electromechanical Analyzer)-Complete

• Consultant to Large Device/Diagnostic, including cardiology products, regarding EUA and Premarket Notification Application (510 k) after EUA - Complete

• Consultant to Molecular Biomarker CNS Drug Development Diagnostic Company (Less than 20 employees) (ELISA, reagents, plasma collection, consumables, microplates, incubators, plate washers, buffers, calibrators, Mass Spectrometry, HPLC-MS) covering GxP, ISO, CAP, FDA CFR, CLIA (Procedures, Maintenance, Laboratory Flow, Training), 21 CFR Part 820, ISO 13485, IVDR, CLSI Guidelines, Risk Mitigation, QC Checks, Samples, Internal Controls and other activities, Average 20 hours per week, 12 months duration, Long Term Project-Complete

• Phone Consult Regarding Regulatory Hurdles for entering the USA, EU, and Japan Markets for R-SUD, Consulting-Complete

• Gap Assessment of Dental Device/Instrument Company (less than 25 employees) covering 21 CFR Part 820, ISO 13485:2016, and HC MDR, SOR/98-282 in three days complete

• Repeat (Third Time) as Lead MDSAP Gap Assessment (Class IIb), as Lead Auditor for Ophthalmic Laser Company- Complete

• Assessment of Regulatory/Quality Requirements for a radiological product according to FDA and EPA requirements-Complete

• Gap Assessment for 21 CFR Part 820 and ISO 13485:2016, Spine Company-Complete

• Gap Assessment of Clinical Sites for Generic Drug Application before potential BIMO Audits by FDA- Complete

• Ad-Hoc Medical Device Services (strategic-De Novo, Clinicals, 510(k), PMA), for Combination

(Drug/Device) for Soft Tissue Repair, 15 hours per week, Six Month Project-Complete

• Senior Consultant to French Company (Pharma/Device) covering global regulatory/clinical requirements

(80 countries), member PRC, Labeling Changes, Vigilance TEAM – Complete

• Consultant, Supplier Audit of Bovine Hide Processor to ISO 22442-1, -2, and -3, - Complete

• Consultant covering 510(k’s), PMAs for Class II /III Device Company-Complete

• Consultant, BIMO Audits, Training of CRO Employees-Complete

• Consultant to Drug/Device Combination Product- In Process, 0-10 hours per week

• Consultant to SaMD client in Australia for radiological devices - In Process, Waiting for Initial Fund Raising

• Acting CCO for SaMD- Complete

• GCP/GDP/GLP/GVP/GxP Internal Auditor/Gap Assessments for Diagnostics, Devices, and Drugs for Italian/US Consulting Firm-In Process

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Colorado Medical Equipment, Inc., Broomfield, CO, 2015 to 2018 Vice President Regulatory, Clinical, and Compliance (Quality) for Three Entities (Colibri Heart Valves, Colorado Therapeutics, and Incubar)

• Directed a cohesive team of directors, project managers, specialists, coordinators, quality inspectors, clinical monitors, and assistants to deliver FDA 21 CFR 820 compliant quality system with design control, risk management, and UDI

• Devised/presented regulatory/clinical/compliance strategy plans for five markets: European Union, United States and Canada, Middle East/Africa, and Asia (Australia, China, Japan)

• Key Contact/Point Person for Venus MedTech utilizing Colibri Tissue (Porcine Pericardium), FIH Studies in China, Pre-clinical Studies in Beijing, using Keystone Heart CEPD

• Managed quality system, regulatory & clinical strategy, and clinical trial documents with compliance, regulatory, project managers, and clinical team members. An integral part of conversations with strategic partners

• Selected with compliance team (project managers) NB for ISO 13485 Certification within the scope of TAVR

• Authored/ reviewed/approved all clinical trial documents for all three entities, commenced five FIH Studies, accelerated a Pre-IDE Strategy with a Modular PMA and PMS

• Implemented Label Review (PRC)with Compliance Team (Project Managers), UDI, MEDDEV 2.7.1 Rev 4, MEDDEV 2.12/1, ISO 14155

• Member ISO 5840 Standard Working Group

• Organized/Directed/Audited additional GLP Studies (ISO 10993, Glutaraldehyde Residuals, Viral Inactivation, Sterilization, Shake/Rattle/Roll, Packaging, RoHS, WEEE, and ISO 22442, Parts 1, 2, 3 and 4) with team members from Engineering, Quality, R/D, Product Management, Business Development, CMO, CSO and CEO

• Three ISO 22442 Gap Assessments of Porcine Suppliers in Illinois as part of the CHV/COT Supplier Program

• Two 510(k’s) with UDI Cleared, Acceptance within One Day, FDA Timeframe 15 Days, both cleared before 90th Day

• Reported to CEO for all three entities: Colibri Heart Valve, Colorado Therapeutics, and Incubar with five to seven direct/indirect reports, including project managers WF Jackson Associates, Ltd., Pleasanton, CA, 2013 to 2015 Senior Consultant/President

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• In-depth (two weeks) GMP/GCP/GVP/GLP/21 CFR 820/ISO 22442 Audit of Manufacturer of Vascular Grafts, France, of only two manufacturing sites NOT to receive a DPA. Function as Project Manager

/Lead Auditor

• Consultant (Administered, Charted, Initiated, Pioneered/Prepared/Trained) SFDA in Riyadh, KSA (FDA

(510k, Combination Products PMA Processes)/EU-AIMD and MDD/TGA/HC/JPAL Reviews), Reuse, Vigilance OEM/OBL, GCP, GVP, GLP, UDI, and Interim Regulations

• Project Manager/Lead Auditor on 21 CFR 820 Mock Audit/BPI of CV Equipment Manufacturer (AIMD, MDD, and UDI)

• Team Member JIP/BPI at J & J to improve supplier quality for medicinal products/biologics/devices, sensors (diabetic test strips)

• Contracted to revise/update an Internal Audit Program covering FDA, EMEA, MDD, JPAL, HC, UDI, and ISO 13485 for $2B Healthcare Company-including Cardiology (AIMD and MDD) products with a revised template for all auditors to ask the same questions, on time and under budget.

• Authored/Project Manager (CMO Approval/Sign Off) Sixteen Clinical Evaluation Reports (CERs) for a Class III Orthopedic (Spine) (MDD)

• Project Manager/Orchestrated/Modified/Refined/ full range of regulatory strategies, FDA Submissions(510K) CE Marks, RoHS, UDI, WEEE, clinical and compliance activities-design control/risk management for multi-national medical products company (Robotic Arm-Software Controlled) in Chennai, India

• Converted 19 STEDs to new CER guidance with CMO Approval/Sign Off

• Consultant to IVD Company for BARDA Project, FluChip-8G Influenza A+B Assay, 510(K) Optovue, Inc, Fremont, CA, 2012 to 2013, Less than 125 employees VP of Regulatory Affairs/Quality Assurance

• Addition to Scope for CE Marking (TUV), less than 60 days and Surveillance Audit with NB (TUV) 25% reduction

• Backlog of five 510(k’s) Cleared

• Instituted RoHS/WEEE/Prop 65 Policies/Procedures

• Resolved Major Compliance Issue with FDA SF District Office, 510(k’s), Off Label Promotion, averted DOJ

• Reported to CEO with eight direct reports, including project managers MiMedx Group, Inc., Atlanta, GA, 2010 to 2012, Startup when hired, now at over one thousand employees VP of Regulatory Affairs / Compliance (Quality)

• Converted prior notified body with Compliance Team to new NB, including updated technical files, less than three months

• Directed Gap Assessment of Bovine Supplier in Australia to ISO 22442

• Generated Due Diligence as to HCT/Ps, 21 CFR 1271, GCP/GVP/GLP, Allografts, leading to significant acquisition

• Four 510(k’s Cleared

• Reported to COO with five direct reports, including project managers 7

Trans1, Inc, Wilmington, NC, 2007 to 2010, Startup grew to over 125 employees Corporate Compliance Officer / VP of Regulatory, Clinical Affairs and Compliance (QA)

• Integral part in IPO process (Selection of FDA Counsel, SEC Reviews)

• Successfully introduced/implemented the AdvaMed Code of Business Conduct and Ethics

• Product into Japan (for clinical studies) without MHLW registration, decreased registration process by 12 months

• Product into India as a custom device (clinical) with Indian CDSCO Approval, speeded registration by 18 months

• Averted MAJOR recall/withdrawal from markets after discussions with the FDA via organizing an independent review committee

• Four 510(k’s) Cleared

• ISO 13485 Audits trended downwards

• Decreased CAPAs

• RoHS/WEEE/HIPPA Compliant

• Commenced and completed two OUS Clinical Feasibility Studies

• Closed out seven clinical studies

• Established a Clinical Management System with staffing, policies, procedures, and training

• Helmed all clinical affairs and clinical research planning throughout the complete life cycle

• Reported to CEO and BOD Compliance Team with eight direct reports, including project managers WF Jackson Associates, Ltd., St. Paul, MN, 1991 to 2007 Senior Consultant/President

All Bullet Points span my career from 1979 to the Present.

• 42+ - Investigational Device Exemptions (IDE), over 10+ Investigator Initiated Research Studies (IIRS)

• 4- Pre-Market Approval Applications (PMA)

• 105+ - PMA Supplements. Amendments –Submitted and approved

• 65+ - Clinical Studies GCP/ICH /ISO 14155; Pre-Clinical Studies (GLP, including 15+INDs) including HC Clinical Studies

• 310+ - 510(k’s) Submitted, Trained by FDA College on 510(k) Review Process (How To)

• 6- BLAs

• 15-NDAs

• 10 PASs

• 105+ PMCFs/PMSRs/PSURs

• 4- Cleared-De Novo Applications

• 6 - Humanitarian Use Device (HDE)

• 5+ Combination Products before OCP was established

• 15+ - Good Clinical Practice (GCP) and BIMO Audits

• 15+ CLIA Applications

• Remediation Project at WR Grace in Reynosa, Mexico, before CD, DPA, or IA were instituted, Reviewed all Complaints/MDRs, RFAIs, and HHEs

• 65+ - Gap Analysis/BPI to ISO and International Regulatory/Clinical/Compliance Strategies, including GCP/ GVP/GLP/ICH/ISO 14155, RoHS/WEEE/GHTF, MEDDEV, UDI, ISO 14971(FMEA, FTA, Risk Analysis) 8

• Consultant (Fifteen Years) to $800 Million DME Manufacturer in Germany regarding submissions, GMP, DME/IDTF, RoHS/WEEE/HIPPA/HIPPA Training and Compliance Activities (Design Control), Prepared over 20+ 510(k’s), and HC Submissions

• 40+ 510(k’s) for Battery Companies, Submitted/Cleared as Battery Replacements with the same Classification as the Device and RoHS/WEEE Compliance

• 25+ - Active Implantable (AIMD) and Medical Devices Directive (MDD) Gap Analysis

• 35+ - Technical Files/Design Dossiers including Essential Requirements

• 15+- IVD Gap Analysis

• 35+-Document Control/Design Control/Risk Management Procedures/Templates/Forms for Class I, II, IIa, IIb, III, and IV

• 24+ - Strategic/Tactical Plans (OUS and US)

• Wrote Design Control Procedures, Forms, Work Instructions, and Templates for the Neurology Division of Medtronic

• Brought TUV PS (SUD) to FDA as First Third-Party Reviewer wrote all SOPS, Pricing Structure, trained by the FDA-Internal College- “How to Review 510(k’s)”, Trained TUV Personnel in US and Germany

• 5+ Years - Instructor as to US (510K, IDE, PMA)/OUS Regulations/Clinicals/Compliance (Design Control)/RoHS/WEEE/ GLP/GCP/GVP/ICH-to Engineering Graduate Students

• 36+ Years of HC Submissions, according to Food and Drugs Act-R.S.C., 1985,c.F-27 from 1987-Present ABBOTT (ST. JUDE MEDICAL, INC.) St. Paul, MN USA and Brussels, Belgium (EU), Small-medium size company Regulatory Affairs Manager and International Regulatory Clinical Affairs Manager 1988 – 1991

• Key Team Member in establishing SJM International (SJMI) operations/distribution in Belgium from a Regulatory/Clinical/Compliance perspective (GCP), from two employees to over fifty

• Directed Regulatory Team to change registrations from distributors (22) to SJMI Division with a Team of B/M Legal Representatives

• Directed/Reviewed and Edited all submissions for the Cardiac Assist Division (IABPs) via 510(k) Process

• Directed/Reviewed and Edited all submissions for the BioPolyMeric Vascular Graft Division via the IDE/510(k) Process

• Directed a Manufacturer’s Registration Scheme (MRS) Audit (UK) at six SJM facilities (St. Paul, Boston, and Puerto Rico) before the transposition of the directives, gained approved supplier status to NHS UK, first heart valve to achieve this status, ability to submit bids for purchasing, increasing sales in the UK by 65%

• Founding Member of the Team that pursued/received approval for the SJM pyrolytic carbon facility

• Directed/led team that commenced and completed retrospective and prospective clinical trials (excess of three hundred subjects, majority in Europe) for pyrolytic carbon, leading to PMAS approval

• Coordinated with the Regulatory Team the regulatory requirements and necessary data for submissions to fifty governments

• Representative for Heart Valve Manufacturers for the initial writing of AIMD, followed by MDD, via IAPM

• Instituted and received approval in Australia, Canada, and Japan for pyrolytic carbon manufactured by SJM with clinical data according to Australian, Canadian, and Japanese clinical requirements with input from engineering, production, clinical, quality, sales, and marketing

• Managed a team of monitors (five) to GCP/ICH Guidelines in foreign locations (primarily in Europe) who supported the usage of SJM cardiovascular products (valves, grafts, IABPs, instruments, rings, bovine/porcine products)

• Prepared ALL FDA Submissions (510k, IDEs, PMAs) for the IABP Division for Submission to the FDA

• SJM Regulatory person responsible for all BioPolyMeric graft submissions, including pre-clinical, biocompatibility testing, bench testing, packaging, residual testing, and clinical studies 9

• Reported to Senior VP of RA/Clinical/Compliance and President of SJMI ADDITIONAL WORK HISTORY

• Director Clinical and Regulatory Affairs: Derma Sciences (Genetic Laboratories, Inc.) 1987 – 1988, Successfully averted recall and withdrawal of 510k. Instituted a Clinical Team composed of a Monitor, a Writer, and a Consulting Biostatistician. First exposure to usage of animal tissue in humans for Porcine Products for Burn Subjects. Reported to President, First Usage of Project Management Tools after obtaining my MBA, Startup company, less than 12 employees

• Clinical Affairs Manager: Abbott (Neuromed, Inc.) 1984 – 1987, First International Submissions to HC and EU before Directives, SCS/DBS, Clinical Trials instituted in the US and OUS, first Orphan Device submissions to FDA. Worked closely with Quality Manager and Regulatory Manager, reported to General Counsel with a dotted line to CEO/Founder, Startup company, less than ten employees

• Clinical Program Manager: Boston Scientific Corporation (Intermedics, Inc.) 1980–1982, First FDA Submissions (510k, IDE, PMA) Internal/External Cardiac Pacemakers plus Accessories, monitoring of studies, along with clinical engineering support to the field. Reported to Senior VP of Clinical Engineering, a small company with less than 150 employees in Freeport, Texas

• Research Assistant: University of North Dakota Medical School Department of Cardiology, 1979 – 1980, First usage of Protocols, Case Report Forms, IRB Approval, Subject Selection, Monitoring, Inclusion/Exclusion Criteria before promulgation of IDE, GCP, and ICH Guidelines. Reported to Chairperson Department of Cardiology/Professor of Cardiology, UND Medical School

• Sales Representative: (Pharmaceutical) Hoffman LaRoche, Inc. 1978 – 1979, Regional Sales Award for Limbitrol, Reported to Regional VP of Sales

• Surgical Assistant, Orderly, Autopsy Assistant Sanford Hospital and Ascension Hospital 1972 – 1975, Assisted in over 245 open heart cases and 100+ vascular implants (mechanical/animal tissue valves), hired/trained/indemnified by two CV surgeons, ER orderly and assistant to a pathologist. Reported to Head CV Surgeon, Sandford Hospital and Chief Pathologist, Ascension Hospital E D U C A T I O N

MBA, University of Minnesota, Moorhead, MN

Bachelor of Arts, Zoology, Chemistry and Physiological Psychology Concordia College, Moorhead, MN Non-Degree via WCC, Orthodox Art, University of Moscow, USSR 10

P R O D U C T S

Products submitted/assisted in developing/audited against quality/regulatory standards: ECGs • EEGs • Spirometers • Ablation-Soft Tissue (Cardiac) • Blood Pressure Analyzers • Breast Pumps • Gamma Detectors • Olfactory Analyzers • Stand Alone Software • Vascular Lab (Portable) • Hearing Aid Analyzers • Cardiac Pacemaker Analyzers • Electronic Stethoscopes • Electronic Wheelchairs • Nerve Stimulators (Peripheral, Foot Drop, Back, Extremities)• Sterilizers • Robotics for Ablation • Programmable Prostheses • Programmable Orthotics

• Pulmonary Analyzers • Prostate Imaging • Skin Dosimeters •Head Coils (MRI) • TENS • Incontinence Stimulators

• Muscle Stimulators • Oximeters (Finger and Tissue) • Sudorometers • Lasers (Fibers, Accessories, LASIK) • Navigation Systems (Cranial, Spine, Orthopedic, ENT) • Pumps (External and Internal) • Heart valves Mechanical/Tissue/TAVI • Wheelchairs mechanical/electric/stair climbing • Orthopedic implants and instruments for fusion/hips/knees/joints • Human Allografts for Various Applications (Burns, Implants, Foot Ulcers, Wounds) • Animal based products for implants • Pacemakers (External/Implantable) and all the accessories, leads/adapters/programmers/batteries, Cardiac, Spinal and Deep Brain • Burn products for grafts • IOLs • Organ Preservation Units • Urological Implants (Penile) • Renal Denervation • Diabetic Test Strips • IVDs • Implantable Cochlear Prosthetics •CLIA-Waived • Sterilization Equipment • Instruments (Manual, Specialized, Disposable, Mechanical, Powered) • Mouth guards for bite disorders • Contract Medical Manufacturers • Breast Implants • Cystic Fibrosis Devices • Walkers/Canes/Hospital Beds • Electrodes (Brain, ECG, EEG, Disposable, Needle, Cortical, Cutaneous) • Epi-Pens • LAL from Crabs for Sterilization Testing • Surgical Instruments from Pakistan • Dialysis Equipment (Tubing Packs, Liquids, Pumps) • Combination Products • Condoms (Female and Male) • Catheters (CV, Urological, Vascular, Infusion) • Head Frames for Neuro Surgery • Ophthalmic devices (Ophthalmoscope, Camera)

• Tympanostomy Tubes • Stents (Vascular, Uretal, Coronary) • Tables (Exam, Surgical, Electronic, Manual) • IABPs

• Annuloplasty Rings •Biologics • POC Testing/Diagnostics • Orthotics • Vascular Closure Devices • Tissue Expanders • Medical Packagers • Glucose Meters • Sterile Solutions for Ophthalmic • Surgery Kits for Continuous Epidural Anesthesia • Heaters for Peritoneal Dialysis Bags • CV Patches • Intravascular Catheters • Eye Charts • Contact Lens Solution • Surgical Staplers and Accessories • Hearing Aids and Accessories • General IVDs • Personal Protective Equipment (PPE) • Soft Tissue Repair • Monitors • Imaging Systems • Ultrasound • Secondary Packaging/Labeling for Medicinal Products (Including DEA Products) • PCR-based molecular assays • APIs • DPs • Cosmetics • Biocides • OTC Medicines • Dietary Supplements • Nitric Oxide • Ophthalmic Lasers • Cleanser

(Dental) • Dental Handpiece-Lubricant • Hearing Aid Analyzers • Spacer (Biodegradable Balloon) for the protection of rectal tissue • Spacer Biodegradable Balloon for the orthopedic market •ELISA •Laboratory Instruments • Reagents •

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