Regulatory Affairs Manager

OBJECTIVE

Sr. Regulatory Management position specializing in Class I & II (US) regulatory submissions and Canadian MDL Class III devices. Currently pursuing strategic opportunities in the global medical device arena focusing on new and innovative products, quality systems management, as well as domestic and international regulatory strategies and compliance.

EDUCATION

M.S., Master of Science, Electrical Engineering, College of Engineering, The Ohio State University, June 1993, Columbus, Ohio. GPA 3.1

B.S., Bachelor of Science, Electrical Engineering, College of Engineering, Rutgers University, May 1991, Piscataway, New Jersey. GPA 3.0

EXPERIENCE:

Sr. Regulatory/Quality Consultant - March 2000 until present

Responsibilities:

Regulatory Affairs 510k Manager – CALISO Corporation:

Responsible for developing client relationships, establishing and securing projects, providing clients with a clear understanding of the FDA program. Developed regulatory strategies for client’s proposed devices and submit Class I & II devices for regulatory clearance. Interact continually with agency on all regulatory issues as they pertain to client submissions.

Sr. Project Manager Quality Systems/Regulatory:

Provided quality systems and regulatory expertise in the design and development of Disruptive Innovation Technology of Class II Medical Devices with Clinical Data/Trials. Partner with external manufacturers with existing quality systems to develop legally marketable low volume devices in a period of 12 to 18 months after design concept for clinical trials.

Strategically assess and advise on the design of devices in accordance with GCP and GLP practices and regulatory requirements. Cross-functional team member in the development of clinical investigation plans (CIP), review of IRB proposals, design and management reviews, review clinical protocols, interact with contract research organizations (CRO). Determine and mitigate risks and hazard, develop application based Hazard Analysis. Provide regulatory strategies for domestic and international markets, quality plans, assure GMP compliance with external manufacturers, FMEA, write and submit 510k’s, IDE’s, and develop Regulatory strategies for new indications and claims. Lead Auditor responsible for managing associate auditors in the evaluation of potential new Contract Manufacturing Organizations in accordance with 21 CFR 820 (QSR regulations) and ISO 13485:2003. Manage Contract Manufacturing Organizations with respect to quality and regulatory affairs for new product development.

Quality & Regulatory Affairs

New Product Development – Served as quality engineering representative for Class I & II medical devices, ensuring all phases of design, development and design transfer adhere to design controls (820.30g). Facilitated risk management process, including, Risk Analysis and FMEA, in accordance with ISO 14971. Establish traceability matrices between use requirements through verification plans, tests, and reports. Developed strategies for software verification and validation activities. Performed detailed design and management reviews. Served as the quality expert for change control process to ensure compliance.

Compliance – Coordinated test activities with Regulatory Affairs departments to ensure regulatory requirements were met both domestically and internationally. Served as the point person for conducting clinical evaluation of device under consideration as well as the electrical and mechanical safety activities and the submittal and approval of three 510k’s in a two year time period. Developed Quality Records to ensure compliance to ISO 13485, ISO 14971, Quality System Requirements (QSR), FDA (CFR part 820), MDD and CMDR directives, and other applicable standards.

Corrective And Preventive Actions – Served on CAPA as well as Quality Review Board to establish company policy and processes. Reduced number of open CAPA’s by 40% in an eight week time frame. Guided engineers in methodology of conducting root cause analysis investigations.

Auditing - Experienced with conducting internal and participating in external audits (including FDA and other third party audits). Provided remediation strategies for clients with audit observations, and warning letters, consent decrees and related issues. Writing/Editing standard operating procedures (SOP’s).

Verification & Validation - Developed strategic verification/validation (V&V) plans for new products. Developed customer, design input (hardware/software) specifications in conjunction with cross-functional teams. Developed verification plans for clinical evaluations. Ensure resource allocation with respect to project defined needs. Coordinate test activities of technicians including but not limited to: environmental tests, electrical and mechanical testing. Maintain test schedule. Coordinated test activities for usability and reliability groups.

Maintained defect tracking database for trend analysis. Conduct weekly product/software assurance group meetings. Provide status updates to project manager.

Manufacturing – Developed and conduced design transfer processes. Developed and conducted IQ, OQ, and PQ for manufacturing processes. Worked with suppliers to ensure compliance with company approved supplier program. Worked on cross-functional team to evaluate, review, and remediate supplier change notices, and SCARS.

Regulatory - International Regulatory Affairs experience including CE Mark, MDD and JPAL requirements, technical files, design dossiers, and device master records. Perform assessment of strategies for foreign countries, Wrote 510k for FDA class II medical devices as well as those items required for the EU. FDA Registrations and Listing experience. Developed device history files (DHF) for new products and performed a “deep dive” of existing DHF’s for preparation of anticipated internal and external audits.

Quality Tools - SAP, Minitab, SAS, defect tracking tools.

Quality/Regulatory Affairs Engineer -Magnetic Resonance Imaging Start-Up Companies

Provided initial applications with comprehensive training to MRI technologists at new customer sites. Coordinate with radiologists to assure that appropriate and correct protocols are installed. Support sales staff as requested to perform sales demonstrations to potential customers. This includes basic system overview, displaying images, scanning and discussion of coil specification and capabilities. Evaluate product performance by evaluating new and existing systems to assure that they are performing properly. Revisit customer sites as requested to provide troubleshooting of customer problems. Responsible for developing verification and validation (V&V) procedures and requirements for New Products. Involved with the submission of 510K for FDA approval of new products. Key member of team involved with obtaining IS0 13485certification. Working knowledge of QSR, IEC, ISO, and NEMA standards required for Class II medical devices. Evaluated new products in controlled access environment. RF coil design in GE and Siemens MRI environment at 1.5T & 3T systems.

Design, development and testing of MRI devices and ancillary equipment and assemblies. Fostered new collaborations with customers and experts in field of magnetic resonance imaging field. Finalize design and specifications for mass production. Created and implementing performance specifications, and related tasks. Designed and developed birdcage and phased array RF coils.

Consultant for Accenture Inc

Design, development, and implementation of such items as databases and network architecture, in very short time periods. Utilized custom reporting tools (Business Objects) to design reporting applications for FDA submission. Aligned technical skills with business practices to add value to Clients. Exposure and experience with client relationships. Projects included, serving as the Chief Information Technologist of the 2000 Republican National Convention in Philadelphia.

Full Time Experience – Regulatory Affairs

B.Braun Medical Inc, Regulatory Affairs Manager 07/09 – 11/10

Regulatory liaison to both German head quarters and Dallas TX facilities for Large Volume and Infusion Pumps. Regulatory supervisor to ensure marketing approval of B.Braun’s device products in US and in other foreign countries. Served as the regulatory liaison with the FDA, Health Canada, other regulatory bodies as well as internal departments related to new product development and changes to existing products. Act in a supervisory capacity for subordinate regulatory personnel. Extensive knowledge of regulation governing the manufacture and marketing of prescription medical devices. Knowledge of how changes in currently marketed products will affect existing regulatory filings.

Intertek, 510k FDA Third Party Reviewer Staff Engineer 01/08 - 11/08

Responsible for determining the substantial equivalence for new medical devices being submitted to the FDA. Specialized in the evaluation of Class I & II and Expansion Pilot Program Devices. Interpreted FDA code of federal regulations (CFR), guidance documents, recognized and non-recognized consensus standards. Worked directly with FDA reviewers to mitigate questions and minimize the request for additional information. Areas of specialization include: Electro-mechanical devices, Radiological based devices, and Medical devices containing software. Performed critical analysis of FDA submissions with medical devices containing software. Determined, based on software level of concern, whether the appropriate submitted documentation was sufficient to establish substantial equivalence to a legally marketed predicate device. This included expertise in interpreting the FDA guidance document on software contained in medical devices, and interpreting software verification and validation processes.

W.L. Gore & Associates, New Product Development Engineer 06/01 – 11/03

Designed and developed MR radio frequency (RF) coils from concept through production. Additional responsibilities include: Interfacing with MRI team to understand the electrical performance, manufacturing requirements, and testing requirements for current and future MR products, electromagnetic modeling and circuit simulation (REMCOM) for new RF coil design, generating test plans for validation testing and production testing, and Testing coils at customer sites. Team member responsible for clinical evaluation of Class II medical devices upon which FDA 510k was granted for commercial marketing. Quality system requirement as well as GMP.

The Ohio State University, Research Associate - Department of Radiology 1993 – 2000

Conducted leading edge research in the area of magnetic resonance imaging. Specialized research in MR angiography, high resolution inner ear imaging, image processing, and RF coil development.

The Ohio State University, Teaching Associate - Department of Electrical Engineering 1992 – 1993

Graduate: Responsible for teaching laboratory experiments, student tutorials, administering exams, and grading assignments.

PROFESSIONAL SOCIETIES

• AAMI Corporate Member, Association for Advancement of Medical Instrumentation

• AdvaMed, Advanced Medical Technology Association

• Regulatory Affair Professional Society (RAPS)

• American Society for Quality, ASQ

• International Society of Magnetic Resonance in Medicine, ISMRM

• The Institute of Electrical and Electronics Engineers, Inc. I.E.E.E.

• Electrical and Computer Engineering Honor Society, ETA KAPPA NU

• National Society of Black Engineers, NSBE

• Acoustical Society of America

QUALITY/TRAINING cGMP for Medical Devices, Six Sigma σ, ISO 13485:2003

COURSE WORK NMR Imaging and Spectroscopy, Medical Imaging, Biomedical Ultrasound,

Cardiovascular Imaging, Radiation from Antennas, Transmission from Radiation, Biological System Modeling, Bio-Instrumentation, Electron Physical Device Theory, Quantum Electron Devices, Fiber Optics, Optics with Laser Light, Comparative Cardiovascular Physiology,

Cardiovascular Diseases, Probability and Stochastic Processes, and Linear Systems, Physiology, Anatomy, Organic Chemistry.

TECHNICAL SKILLS C/C++, Visual Basic, Visual C, SQL, Unix, MathCAD, MATLab, Maple V, Remcom (finite element analysis and simulations for RF coil design) and Interactive Data Language (IDL), RF coil development, Biological System Modeling, Experience with Radiological modalities (MRI, CT, Nuclear Medicine, and Angiography, Positron Emissions Technology)

GRANTS & AWARDS

• National Institutes of Health: “High Resolution MRI of Cochlear Grant.

• Fluid Motion”, Dissertation Grant in Communication Disorders, 1997.

• National Institutes of Health: “MRI in Sensorineural Hearing Loss with 500mm Resolution, Supplemental Grant, 1993.

• National Consortium for Graduate Degrees for Minorities in Engineering and Science Fellowship (GEM Fellow), 1991.

• Merck Corporate Engineering Scholarship, 1988

• G.E. Lewis Latimer Award, 1988

• Mack E. Williams Scholarship, 1987

510k’s

510k Number Company Product Code Device Type Status

111129 Medi-Kahn KYZ Lipo Suction Device In Process

100236 Stair Systems LLZ PACS System Written

083455 Medi-Kahn MUU Liposuction Device Written

087207 MedX Electronics ILY Tethered Laser Reviewed for FDA

083030 EMSI GZJ/IPF TENS Device Reviewed for FDA

082816 GE Medical Systems JAK Computed Tomography X-ray System Reviewed for FDA

081905 Accuflow and Accuflux Elastomeric Infusion Pump MEB Infusion Pump Reviewed for FDA

081215 Kjaya Medical LLZ PACS System Reviewed for FDA

081985 GE Medical Systems LLZ PACS System Reviewed for FDA

081644 ConMed GEI Electrosurgical Device Reviewed for FDA

081841 Amplivox ETY Auditory Test Impedance Reviewed for FDA

081916 GE Medical Systems LNH MRI System Reviewed for FDA

081143 Biomers DYW/DZC Orthodontic Bracket Reviewed for FDA

081028 GE Medical Systems LNH MRI System Written

080290 American Radiologist Network LLZ PACS System Reviewed for FDA

052200 MR Instruments MOS MRI RF Coil Written

040937 MR Instruments MOS MRI RF Coil Written

031089 WL Gore & Associates MOS MRI RF Coil Written

023679 WL Gore & Associates MOS MRI RF Coil Written

013810 WL Gore & Associates MOS MRI RF Coil Written

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