Former FDA inspector with thirty-one years of experience.  Professional consultant specializing in mock FDA compliance audits for the Medical Device industry.

Titles Held: Senior Consultant; Regulatory Manager; Medical Device Specialist

• Quality System and Regulatory Affairs from an FDA Perspective; Provide training for FDA’s Quality System Regulations for the Medical Devices industry
• Provide expertise in how to handle an FDA inspection; understanding the Quality System Inspection Technique (QSIT) for an inspection by FDA; Comparing FDA’s QSR to ISO 13485 Standard Compliance
• Working knowledge of Medical Devices Classes l through III and all types of devices, mostly in electromechanical, plastics and latex products
• International experience conducting various inspections and audits of products and facilities in Malaysia, Mexico, Germany, Switzerland, Indonesia, England and reviewed clinical studies for medical devices in Thailand
• Experience working with Medical Device manufacturers of all sizes, with multiple product lines and multiple sites

Nineteen years of direct hands-on experience in Class I/II/III medical devices and In-Vitro diagnostics.   Extensive experience in Pharmaceutical and Biologic operations in the areas of regulatory affairs, compliance, validation and quality systems to ensure compliance with FDA and international regulations.

Titles Held: Director of FDA Regulations and Compliance; Corporate Director of Technical and Regulatory Compliance; Corporate Manager of QA/RA; Manager of Quality Engineering

• Expertise in executing process validation, remediation, supplier qualification, training, internal/due diligence audits and policy/procedure development
• Skilled in Risk Management/Assessment; ISO 9001/13485/14971; MDR/AE/product complaints and CAPA’s
• International experience in Japan, EU and Canada regulatory bodies/agencies; also MDD 93/42/EEC and CE Mark and Notified Bodies
• Experience with PMA’s, IDE’s, 510(k)’s, NDA’s and e-CTD/CMCs submissions
• Knowledge with inspection readiness for manufacturers

Thirty-five years of experience in Regulatory (FDA) Submissions, FDA and ISO Quality Systems for the Medical Device and IVD industry.  Additional experience with Quality Assurance, Manufacturing, Clinical Affairs, Medical Services, Customer Services and Instrument Repair Services.

Titles Held: Vice President of Quality Assurance/Regulatory Affairs; Vice President of Clinical, Quality and Regulatory Affairs; Director of QC/QA

• Clearance and Approval of over thirty-five 510(k)’s, PMAs and BLAs
• Managed three IVD corporations to ISO 9001 and 13485 Certifications
• Developed and Commercialized 8 lVD’s (R&D)
• CE Marking, Canadian Product Registrations, experience working in Germany and Japan
• Extensive knowledge of In-Vitro Diagnostics, all classes including Biologics

Regulatory and quality systems specialist with twenty-three years of medical device experience.  Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.

Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer

• Experience Conducting mock FDA inspections and QSR training
• Worked for Start Up companies to large medical device firms
• Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
• Management and coordination of recalls and corrections, FDA inspections and related events
• Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)

ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.

Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services

• Proven capability to accomplish results in different countries and varied business functions
• Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
• Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
• US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
• Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001

Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas.  Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

• Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
• Strong international experience including international product registrations, CE mark approvals and import/export activities
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
• Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
• RAC certified with extensive knowledge with combination drugs devices

Twenty years of experience in the Medical Device and Biotechnology industries developing, implementing and maintaining global regulatory affairs, compliance and quality assurance strategies and systems.  Strong background with FDA Quality Systems regulations, including ISO 9000:2000, 13485:2003, CMDCAS, MDD, IVDD and HIPAA requirements.

Titles Held: Director of Regulatory Affairs/Compliance Assurance; Senior RA Specialist; Manager of Quality Assurance; Senior Quality Engineer

• ISO certification and surveillance
• State licensing and Facility registration
• QM & SOP writing; Failure investigations
• International experience: Pakistan, Costa Rica, Mexico, EU, Canada, Japan and Australia; CE Marking
• Certifications: CQA, RAC, Lead Auditor Certification

Twenty years of experience in the areas of Medical Device, Pharmaceutical, Electrical Control, Electronics, and Air Compressor industries.  Strong engineering experience in both Process and Equipment validation.

Titles Held: Senior Validation Engineer; Project Manager; Principle Engineer; Senior Manufacturing Engineer; Senior Mechanical Engineer

• Experience with new product introductions; mechanical designs; line relocation and start-up
• Equipment installation, validation protocol creation and execution and operator training
• Hands-on experience with high-vacuum/high-temperature equipment, high-pressure hydraulic systems, high-pressure air systems, clean rooms and equipment, and high-volume aqueous washing and solvent washing/degreasing systems
• Expert in designing, implementing, and executing FAT, IQ, OQ, PQ, and PV protocols
• Experience with Class II and Class III medical devices

Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

• Expert in Process and Software Validation; Knowledgable QSR Trainer
• Extensive experience with FDA Inspections and Quality system Audits
• Experience with Class II Intravascular Devices; clinical trials
• Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
• Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor

RAC/CQA professional with over twenty-five years experience with Medical Device Regulation in Compliance Management, Regulatory Affairs, Quality Systems and Clinical Affairs. Specializes in creative regulatory strategies to expedite product registrations.

Director of Regulatory Affairs; Corporate Director, RA/QA; Manager of Regulatory Affairs; RA/Clinical Associate

• Develop Design Control Systems and Implementation; experienced in working with product development teams to get medical devices to market in a timely manner
• Strong experience with Regulatory Compliance Programs, GMP/QSIT Audits, and Gap Analysis
• Develop and implement ISO 13485 compliant Quality Systems
• Possess extensive knowledge and expertise of FDA device regulations, EU Medical Device Directive (MDD), Notified Body Audits, FDA QSIT inspections, and IRB/IDE submissions
• International Submissions: Design Dossier and Technical File Development; Lead CE mark projects
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees