Regulatory Marketing Compliance Quality Assurance Medical Device Expert Witness

Provides Opinion & Testimony In:

Regulatory Affairs, Clinical Affairs, Quality Assurance, Regulatory Compliance, Medical Device, Combination Product, Design Dossier, Medicinal Dossier, Director, Client Manager, Project Manager, 510(k),515i, Pre-IND, IND, Pre-IDE, IDE, HUD, USAN, HDE, PMA, Pre-Sub, Recall, Correction, CTA, FDA, CDRH, CE, OUS, MAF, Pre-submission, Pre-IDE, De Novo, Recall Correction, Appeal, Supplement, Annual report, FSN, FMEA, CER, FSCA, MDEL, MDR, 13485, 10993, 14971, 60601, CMDR, PMS, PMCF, NCA, EFTA, Apostille, legalization, CFG, CFS, QMS, QC, 21 CFR 820, 21 CFR 801, 21 CFR 803, MDL, 21 CFR 807, MEDDEV, NB, Product Liability, Infringement, Patent Infringement, Injury law,CE, TUV, Intertek, SGS, DGM, NSAI, SNCH, BSI, UL, Medicinal Consultations, MHRA, MPA, ETAT, License Applications, Health Canada, TGA, Covid-19, EUA

Regulatory Affairs professional in medical device, IVD, combination products with FDA, HC, TGA, CE strategies. Expert Witness (plaintiff) and Material Witness (defendant) in recorded deposition.

510(k): K060288, K073092, K073093, K090182, K090190, K090709, K093431, K100076, K100595, K101401, K101839, K102596, K103346, K110110, K110282, K110793, K110794, K111226, K111595, K113112, K120552, K120875, K121812, K123943, K130424, K131045, K131144, K131323, K131557, K131814, K132899, K133222, K140386, K141002, K150219, K150454, K152204, K152636, K152819, K153548, K160472, K160475, K160977, K161062, K161734, K161743, K161931, K162011, K162355, K162862, K162943, K163385, K163646, K170215, K170706, K170741, K171157, K171208, K171734, K173558, K173749, K180183, K181093, K181580, K183425, K183453, K190806, K191036, K191158, K191102, K191851, K192015, K193239, K200282; IND: 105563, 108372; IDE: G110180, G110194, G120159; HC CTA: 149462, 149988; Docket: (DE) N14C-03-185 MMJ CCLD, (NH) 16-md-2753-LM; USAN: xx-130/9459; HUD: 09-0213; MAF: MAF-1624, MAF-1677; 513g: C170051, C190030, C190080, C200047; Q-Submission: Q120079, Q120188, Q131525, Q140005, Q140006, Q140629, Q141168, Q160673, Q161482, Q170165, Q180049, Q180954, Q181043, Q182262, Q190841, Q192239, Q192288, Q192493, Q200088, Q200567, I070775, I090555, I090626, I100414, I100771, I100795, I110249, I110270, I110442, I110287, I110664, I110766, I111060, I120752, I184916), 515i (K063723, K083111; De Novo:K090423; DWPE Import Alert Petition: 516310; Recall Correction: Z-0115-2014;
Appeal: K100771, Color Batch Certification: 190001PO50; HC ITA and CTA

Covid-19: PEUA, EUA, and Canada Interim order.

CE: BSI, DEKRA, DGM, Intertek Semko, NSAI, SGS, SNCH, TÜV Rhineland, TÜV Süd;
Competent Authority Consultations: ETAT, MHRA, MPA.
Meetings: FDA, Notified Bodies, Legal Counsel, HC, TGA.

MEDICAL DEVICE EXPERIENCE

Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches.

Biomaterials: bone void fillers, wound flushing solutions, dermal filler syringe/actuators, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, antimicrobial coatings, Resorbable Hemorrhoid Staple/Suture Kit, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser andbandages, Vaccine Injector, ICG Contrast Scope.

Orthopedic/Dental/Ophthalmic: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x-ray equipment, IOL, contact lenses and contact lens solutions.

General Surgery: surgical film, pressure mattresses, cryobiopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes, tunneler, suture wings, OR fire prevention devices, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations.

Hardware/Software: neonatal clinical trial software, firmware, Body Composition Software, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, Biological Indicators, Chemical Indicators, Process Challenge devices (PCD), powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices, volumetric/planar dynamic image processors with parametric mapping.

Reusable: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, Trans Anal Introducers, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes, epidural infusion pumps.

EMPLOYMENT HISTORY

Chief Regulatory Officer
Licensale Inc (an Arazy Group company)
April 2012 –Present

Developed successful regulatory strategies, submitted and received approvals for 510(k), MAF, HUD, CE, TGA, HC Licensing, CTA, Q-submission, and Annual Reports (IDE/PMA). Assisted with development of the Licensale platform which manages simultaneous global regulatory applications. Managed experts and testing labs globally to complete client projects and respond to AI requests on time. Managed human factor/usability studies, biocompatibility studies, sterilization and disinfection validations, packaging validations, shelf life and life of device programs, electrical and EMC safety testing, software validations, performance testing, risk assessments, conditioning and cleaning validations for reprocessed equipment, and radiation safety reporting as part of client applications or AI responses. Established substantial equivalence discussions to predicate devices to support 510(k) applications, CER literature reviews, and 515i reclassifications. Performed Clinical Evaluation Reports (CER), regulatory strategy surveys, recalls and PMS, and other RA support functions. Redact documents and request documents via FOIA. Provide reports when needed on regulatory and/or quality topics for medical devices and combination products for US, Canada, and European markets. Presented expert opinion and material witness testimony in deposition (with video recording).

Director of Regulatory Affairs
Atrium Medical Corporation – (Maquet-Getinge Group)
March 2008 – April 2012 Hudson, NH

Developed successful regulatory strategies, submitted and received approvals for employer 510(k), HUD, IDE, IND, USAN, PMA (pending), CE, HC Licensing, TGA, CTA, Q-
submission, and Annual Reports (IDE). Provided RA support on multiple clinical investigations, several were conducted under IDE or IND approval. Managed R&D resources to complete regulatory applications and respond to AI requests on time. Established substantial equivalence discussions to predicate devices to support 510(k) applications and CER literature reviews. Performed Clinical Evaluation Reports (CER), regulatory strategy surveys, and other RA functions. Managed selection and usage of notified bodies, developed medicinal dossiers to support competent authority reviews of combination product CE applications. Assisted with private reimbursement code development for product, applied for and received USAN name for a new molecular entity (NME) entered in the USP. Attended meetings with FDA and notified bodies, attended an appeal hearing. Completed a regulatory survey for national distribution of a pharmaceutical to comply with pedigree and state licensing requirements.

Director RA/QA
Spire Biomedical, Inc. (Spire Corp)
March 2006-March 2008 Bedford, MA

Developed successful regulatory strategies, submitted and received approvals for employer 510(k), CE, HC Licensing, and TGA. Managed R&D resources to complete regulatory applications and respond to AI requests on time. Established substantial equivalence discussions to predicate devices to support 510(k) applications and CER literature reviews. Performed Clinical Evaluation Reports (CER), regulatory strategy surveys, recalls and PMS, and other RA support functions. Managed selection and usage of notified bodies, developed medicinal dossiers to support competent authority reviews of combination product CE applications. Managed QMS system to maintain ISO 13485, SOR/98-282, and Part 820 compliance. Ensured compliance to regulatory requirements and QMS regarding supplier controls, manufacturing, sterilization, promotion and labeling, complaint handling, and PMS requirements. Implemented investigations into complaints, represented employer during product liability lawsuits and defended employer in cases where suspect product was not the root cause of the event. Managed global customer complaint handling, Advisory Notices, Recalls. Maintained technical files, DMRs, DHFs, and design dossiers as state-of-the-art. Managed MDR reporting and vigilance while adhering to HIPAA. Managed CAPA and MRB programs, supported the (SOX) Sarbanes- Oxley Oversight Committee. Wrote and reviewed supplier agreements, distribution agreements, and direct sales agreements. Advised on corporate quality and regulatory compliance issues.

Director RA/QA TESco Associates, Inc. March 2000-March 2006 Tyngsboro, MA

Developed successful regulatory strategies for clients as an OEM. Performed regulatory strategy surveys, assisted clients with recalls and PMS, and other RA support functions. Managed selection and usage of notified bodies for certifications, developed and maintained Design History Files (DHF), Device Master Records (DMR), Quality System Record (QSR), and device History records (DHR). Managed QMS system to maintain ISO 13485, SOR/98-282, and Part 820 compliance. Ensured compliance to regulatory requirements and QMS regarding supplier controls, manufacturing, labeling, complaint handling, and discrepant material requirements. Implemented investigations into complaints, represented employer during product liability lawsuits and defended employer in cases where suspect product was not the root cause of the event. Managed global customer complaint handling, Advisory Notices, Recalls. Maintained technical files and design dossiers, FSCA, FSN, DMRs, DHFs. Managed MDR reporting and vigilance while adhering to HIPAA requirements. Managed CAPA and MRB programs, senior management review meetings, and internal audits including supplier audits.

Production/Compliance Engineer, Certified Auditor Trans-Lux Corp.
February 1997-March 2000 Norwalk, CT

QA Test Engineer
DuPont Chemistry Systems (Dade-Behring, Siemens Medical)
June 1996 – February 1997 Newtown, CT

AMHS Quality Engineer Intel Corporation (Daifuku) August 1994-June 1996
Rio Ranch, NM

QA/Test Engineer Robohand, Inc.
November 1993 – August 1994 Monroe, CT

EDUCATION/MILITARY

RAPS: RA Certificate – Medical Devices, 2008

Degree: Dipl.-Ing. (FH) Werner Siemens Schule
February 1988 – November 1993 Stuttgart, Germany
Computer Science/Electronic Engineering GPA 3.6

Internship: Deutsches Zentrum für Luft und Raumfahrt (German National Aerospace Agency) June 1993 – November 1993
Stuttgart, Germany

Control Data Institute (CDI), “C Language” Programming Certificate, Stuttgart, 1992

VolksHochschule Stuttgart, German Language, read and write, 1988

Department of Defense (DOD) Mapping School, Technical Drafting Specialist, 1984

US Army, Corporal, Feb 1984-Feb 1988 (Good Conduct Medal, Army Service Ribbon, Army Lapel, Army Achievement Medal, Overseas Service Ribbon, M-16 Rifle Marksmanship Badge, Grenade Sharpshooter Badge.)

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