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
To be professionally challenged at all times, take pride and ownership in regulatory and clinical projects, and be a major asset to my employer and clients by identifying and implementing effective methods of overcoming anticipated challenges on regulatory/clinical projects.
- Past positions have been RA/Clinical and RA/QA at various levels including the roles of specialist, director, client manager, project manager, third party, expert witness, and consultant.
- Previous lead regulatory person on device and combination product and clinical submissions including 510(k), 515i, Pre-IND, IND, Pre-IDE, IDE, HUD, PMA, Pre-Sub, Recall, Correction, CE, and OUS registrations.
- Expert witness testimony at trial and in deposition, product liability, infringement, patent infringement, injury law.
- Recent clearance/approvals include 510(k) (K060288, K073092, K073093, K090182, K090190, K090709, K093431, K100595, K100076, K101401, K101839, K102596, K103346, K110110, K110282, K110793, K110794, K111226, K111595, K113112, K120552, K120875, K121812, K123943, K130424, K131045, K131144, K131323, K131557, K131814, K132899, K133222, K141002,P140003, K150219, K150454, K151937, K152204, K152636, K152819, K153256, K153548, K153699, K160472, K160475, K160686, K160688, K160977, K161062, K161734, K161743, K161931, K162011, K162862); IND (105563, 108372); IDE (G110180,G110194, G120159), HC CTA (149462, 149988), USAN (xx-130/9459), and HUD ( 09-0213).
- Other recent submissions include MAF (MAF-1624, MAF-1677), Pre-sub/Pre-IDE (Q120079, Q120188, Q131525, Q140005, Q140006, Q140629, Q141168, Q160673, Q161482, I070775, I090555, I090626, I100414, I100771, I100795, I110249, I110270, I110442, I110287, I110664, I110766, I111060, I120752, I184916), 515i (K063723, K083111), De Novo (K090423), Recall Correction (Z-0115-2014), and Appeal (K100771).
- Recent submission experience includes CE (TÜV Rhineland, TÜV Süd, Intertek, SGS, DGM, NSAI, SNCH, BSI, UL), medicinal consultations (MHRA, MPA, ETAT), license applications (India, Canada, Australia), and OUS registrations (Latin America, Asia, and Eastern Europe).
- Participated in numerous meetings, depositions, expert witness testimony, and conference calls with FDA, notified bodies, legal counsel, competent authorities (Health Canada, TGA, SFDA, COFEPRIS, and MHFW), and attend meetings in Silver Spring, MD.
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, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages.
Orthopedic/Dental: 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.
Accessories: tunnelers, suture wings, 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, 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, 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.
Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, 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.
General Surgery: surgical film, pressure mattresses, cryo-biopsy 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.
IVD: HIV antibody test, chemo urine culture test kits, pregnancy tests,
Chief Regulatory Officer
Licensale Inc (Arazy Group Medical Device Consultants)
March 2008- Present
Mill Creek, WA
World leader in global regulatory consulting for medical device and IVD products. Provide product registration services in more than 80 countries and implement regulatory affairs strategies using the most advanced methodologies, which allows for multiple simultaneous submissions through one comprehensive, quick and cost effective process “Licensale.com”.
- Develop regulatory strategies and prepare FDA and OUS regulatory submissions, and perform audits and site inspections.
- Prepare and manage 510(k), MAF, HUD, MDL, IDE, PMA, HC Licensing, CTA, and Annual Reports (IDE/PMA).
- Assist with development of Global Regulatory Intelligence Management System (GRIMS) and with the development of the Licensale expert portal and system.
- Oversea and manage RA and non-RA experts globally, ensuring client projects are completed correctly and on time.
- Manage and liaise 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
- Develop challenging substantial equivalence discussions to predicate devices and rationalize differences between proposed and predicate devices. Develop challenging discussions comparing devices reported in articles to subject devices during clinical literature reviews for CE submissions or 515i reclassifications.
- Supervise development and submission of various submissions globally, working with OUS counterparts to select fastest regulatory strategy.
- Perform Clinical Evaluation Reports (CER), regulatory strategy survey reports, state registrations, GRIMS database label entry, product testing strategies, and other RA support.
Director of Regulatory Affairs
Maquet-Getinge Group – (Atrium Medical Corporation)
March 2008-April 2012
Manufacturer and distributer of Class II and III products, including Drug Eluting Stents, Bare Metal Coronary Stents, PTFE Covered Stents, Drug Perfusion Catheters, PTCA Catheters, Embolectomy Catheters, Dry and Wet Chest Drains, Electronic Chest Drains, Thoracic Catheters, Convenience Kits containing RX and OTC Components, Antimicrobial Grafts and Patches, and Antimicrobial Mesh/Film/Plugs in the global marketplace.
- Convinced notified body to drop “12 month/100 patient” clinical requirement and accept clinical literature review leveraging a proposal from another notified body. Saved company the costs associated with a 12 month multi center 100 subject study.
- Performed clinical literature evaluation (CER) reports, saving the cost associated with a third party conducting review.
- Appealed a TGA application audit request, saving employer time and cost associated with the audit.
- Used published off-label data to add renal indication to an iliac stent, without a clinical trial, saved trials costs.
- Created new Australian private reimbursement codes based on clinical evaluation for a higher reimbursement.
- Submitted application with a drug company for study investigators to get free drugs for a large multicenter clinical trial, saving company reimbursement costs for the study drugs.
- Found CA that does not charge for medicinal consultations and received CE registration on multiple combination devices without the costs associated with CA consultation.
- Identified ways to comply with regulatory requirements for foreign registration of products which are made in the USA but not authorized for sale in the USA using unique combinations of CoFS, CFG, and COE.
- Changed from NSAI who required dossier reviews for all Class IIa and IIb products to BSI who does not, increasing time to market for all Class II products and eliminating review costs.
- Presented to FDA which was accepted allowing the pooling of data between a multicenter IDE and a physician sponsored single site IDE, saving enrollment of 10 patients at 2 or 3 additional sites.
- Added significant number of vascular graft codes to Canadian license using Faxback, saved company cost of application.
- Managed strategic partnership between employer and Toxikon for special pricing, lead times, dedicated study coordinator, and permission to test products on animals designated for expiration from other sponsor studies.
- Filed an appeal with Director at POS CDRH, Division Director, and Branch Chief.
- Work as lead regulatory affairs member on developing regulatory strategies for FDA, Canada, Australia, and CE and preparing, submitting, and managing the submissions for products and clinical investigations globally.
- Performed annual reporting and evaluated labeling and product changes to determine regulatory requirements.
- Developed regulatory strategy for products containing electronics, RoHS/WEEE and Spent Batteries guidance.
- Attended meetings/conference calls with FDA, TGA, COFEPRIS, SFDA, and MHFW (India).
- Developed RA plan for kit containing Lidocaine to comply with PDMA including Pedigree and State Licensing/Distribution requirements for Rx/OTC.
- Performed clinical literature reviews and risk management for EU and AU submissions.
- CE on PTFE Covered Renal Stent, CE on vascular grafts with antimicrobial coatings, CE on Coronary Stent.
- Pre-PMA work on Soft Tissue Liquid Emulsion Film, Drug Eluting Stents, Drug Eluting Film and Mesh, Covered Stents
- 510(k) Antimicrobial Mesh, Antimicrobial Graft, Film, and Pre-IDE/IDE for clinical trials.
- Global Product Registration, Pre-PMA, 510(k), CE, Pre-IDE, IDE, state RX licensing, pedigree.
- Prepared “IND” for dual drug study to change standard-of-care to IC (intra coronary) versus IV; with and without aspiration. Four arms, 2 study devices, two study drugs, multi-center, randomized, single blinded.
- Prepared and submitted “Pre-IDE Meeting” submission packet for new drug entity and carrier on coronary stent including USAN registration application for new drug adopted chemical name, IND for safety study in healthy human subjects (PK, TK, metabolism, TWEEN 80 excipient, MTD, CMC, bioactivity and stability), and phase one FIM, phase 2 pivotal for CE, and phase 3 pivotal for PMA.
- CE on Coronary Stent and set up platform for DES.
- Prepare and submit Canadian IDE and License Applications for Class IV devices/clinical trials also special access.
- Prepared CTA/IDE/IB for clinical trials to add Coarctation of the Aorta indication to iliac/renal stent.
- Developed conformity assessment routs for TGA applications.
Spire Biomedical, Inc. (Spire Corp)
March 2006-March 2008
Manufacturer and distributor of Class III split-tip and fixed-tip chronic Hemodialysis catheters and drug coated catheters for the treatment of ESRD and acute chronic kidney failure caused by hypertension and diabetes.
- Located and interpreted FDA guidance to change pyrogen testing frequency from a lot basis to a quarterly basis using product pooling which saved in testing fees.
- Changed notified body from TUV to BSI based to save the company money through lost market potential and through better pricing and a decrease in design dossier review time, leading to quicker CE approvals and earlier product releases to market.
- Instituted reimbursement code guidance to improve reimbursement.
- Worked with supplier to validate alternate ATTEST model for load BI sterility testing leading to an annual savings in testing costs.
- Identified inconsistencies in product labeling as primary root cause for non-conforming products and lost revenue through product rework and customer complaints.
- Developed innovative regulatory strategy for CE Marking drug coated catheters by entering the EU through a newly executed MRA with Switzerland. Saved 2 years and CA review costs per submission based on traditional filing strategies using an EU CA.
- Redesigned IFUs allowing for back-to-back runs reducing IFU costs by two/thirds.
- Changed components in catheter kits extending expiration dates for product shelf life by 3 years.
- Qualified product packaging for application of the “Green Dot” and opening up new business with EU customers contributing to sales annually.
- Qualified company as a small business with the FDA, decreased Medical Device User Fees by 50% (includes the drop in user fees signed by congress from fiscal 2007 to 2008).
- Submitted 510(k) premarket notifications for changes to design and manufacturing process and used approvals to eliminate one royalty agreement against design and deflect one patent infringement law suit against manufacturing process.
- Provided regulatory support to legal counsel on various product liability law suits resulting in quick mediations.
- Manage global customer complaint handling system, Advisory Notices, Recalls (MDD Vigilance, MDR, Post Marketing, CMDR).
- Pre-PMA and Pre-IDE on Selenium Dialysis catheter.
- Monitor/Sponsor Clinical Investigation (Patient Consent, CIP, Endpoints, GCPs).
- Prepare and submit design dossiers and medicinal substance dossiers for CE marking.
- Maintain Health Canada device licensing and Australian TGA licensing.
- Manage ISO, FDA, MDD, CMDCAS quality management system. Maintain all technical files, DMRs, DHFs, and design dossiers as state-of-the-art.
- Manage MDR baseline reporting, MDL, and other regulatory functions. Comply with FDA requests for additional information (AI) and navigate around HIPAA laws with customers.
- Prepare and submit 510(k) submissions and maintain DHFs. Reference protection of confidential information from FOIA on all submissions.
- Maintain reimbursement codes for US and EU based customers.
- Manage and create submissions and regulatory strategies including design dossiers and medicinal dossiers for drug coated catheters both CE and FDA clearance, work with notified body, EU Representative, FDA, and national competent authorities. Create and submit Medicinal Substance Dossiers.
- Manage and helped develop a low-temperature EO sterilization process and determine all biocompatibility testing and validation requirements (cytotoxicity, pyrogenicity, genotoxicity, sensitization, EO residual, sterility, Bioburden, B&F, fractional cycles, sub-lethal) and methods to meet those requirements.
- Manage packaging seal validations, permeability of materials, shelf life studies, and shelf life extension programs using accelerated and real-time data.
- Develop regulatory strategy for US market (SE and Predicate Devices, 510(k) paradigm, QSR-GMP).
- Help develop and approve marketing claims, product brochures, and IFUs.
- Manage suppliers and perform on-site supplier audits. Trend supplier performance, trend complaints, trend CAPAs.
- Interface with distributors and review sales reports to ensure distributors maintain lot traceability. Perform sales tracings.
- Maintain and refine QMS processes and process interactions. Direct auditing team while performing 13485:2003, CMDR SOR/98-282, and MDD 93/42/EEC audits, CAPA implementation, re-audits, and CAPA effectiveness verification.
- “Management Representative” and present employer during FDA, notified body, and customer audits.
- Provide corporate level risk management and act as Corporate Compliance Director, member of the (SOX) Sarbanes-Oxley Oversight Committee. Responsible for maintaining SOX compliance.
- Write and review supplier agreements, distribution agreements, and direct sales agreements. Advise corporate on quality and regulatory compliance issues.
Director RA/QA TESco Associates, Inc.
March 2000-March 2006
Manufacturer of class II and class III resorbable implants realized through injection molding or extrusion using copolymers, copolymer blends, and composites and an analyzer of molecular weight and resorption kinetics through the use of solution viscometry analysis.
- Utilized open CAPA to secure reimbursement of legal fees from customer after legal department failed to be reimbursed.
- Helped work on developing a coronary bioabsorbable stents and supported the customer on their PMA submission.
- Led firm through ISO certification and 13485:2003 upgrades resulting in new business in the EU which led to an increase in sales. Certification also lightened customer audit requirements cutting customer audit expenses by half.
- Negotiated aggressive contract with raw material supplier to cut cost for material. Included increase in length of payment terms by 60 days and included a 20 kg material consignment agreement.
- Researched, analyzed, and presented savings plan to largest customer by switching over product lines from a competitor, this transfer resulted in an increase in sales.
- Supported President during patent infringement investigation.
- Implemented an effective supplier agreement with primary suppliers which provided protection from patent infringement and product liability law suits.
- Managed auditing systems (ISO, customer, notified or regulatory body, supplier, internal).
- Maintained quality management system (21 CFR 820 & ISO 13485:2003) and was “management representative”.
- Supported President during a product liability law suit which was resolved through mediation.
- Supported President during due diligence audits and attempted M&A and JV negotiations.
- Managed environmental management system (41 CFR & ISO 14001:2004).
- Coordinated with FDA and foreign regulatory agencies regulatory compliance.
- Interfaced with customers regarding product and business development.
- Negotiated client development agreements, quality assurance protocols, and manufacturing validation protocols.
- Oversaw document control, record retention, and change control.
- Verified compliance of procurement, receiving, and shipping procedures.
- Provided guidance to engineers regarding process and equipment validation and verification.
- Assisted with cleaning protocol verification, clean room certification, and bio-burden testing.
- Managed customer complaint, non-conformant material, and CAPA systems.
- Implemented appropriate statistical process controls to maximize production yields and minimize quality deficiencies.
- Wrote and evaluated product testing protocols, accept/reject criteria’s, and inspection methods.
- Managed equipment master calibration list and equipment master asset list.
- Installed and implemented LabTrack software system and networking.
- Negotiated sales agreements and contracts.
- Negotiated strategic agreements with suppliers.
- Presented organization and supported legal counsel during product liability suites
- Created quality systems and regulatory compliance systems.
DuPont Chemistry Systems (Dade-Behring, Siemens Medical)
March 1999-March 2000
Medical device manufacturer that specializes in discrete clinical analyzers that help identify patient disease or drug use through the photometric measurement analysis of solution diluted test pack samples.
- Performed final inspections and validated product before release.
- Verified product was manufactured correctly.
- Performed final calibrations and adjustments.
Abiomed, Carl Zeiss, Dell, Kaneka, Karl Storz, Maquet, McKesson, Mitsui, Proctor & Gamble, Smith & nephew, Terumo.
Degree: Dipl.-Ing. (FH) (MSEE “Bologna Declaration” of 1999)
Werner-Siemens School (IB/BBZ)
Computer Science/Electronic Engineering
Internship: Deutsches Zentrum für Luft und Raumfahrt (German National Aerospace Agency)
- Control Data Institute (CDI), “C Language” Programming Certificate, Stuttgart, Germany
- RAPS, RA Certificate – Medical Devices, 2008