A driven professional with eleven years experience. Extensive knowledge in Documentation for both the Medical Device industry as well as Engineering firms.

Titles Held: Documentation Coordinator; Documentation Technician; Business Manager

• Possesses a great deal of experience in a variety of areas including an in-depth knowledge of computers, peripherals, installing hardware, software and troubleshooting
• Experienced with Class II and III medical devices, mostly disposables
• Efficient with QMIS database, SAP and CAD
• Strong documentation skills, reporting, coordination and follow through
• Has worked with start up to large medical device firms

Six Sigma Green belt professional experienced in Quality, Compliance and Regulatory for the Medical Device, Biologics, Pharmaceutical and Combination Products industries.  Expertise in preparation and evaluation of Regulatory, Compliance and New Product Development Systems.

Titles Held: World-wide Manager Strategic Quality Combination Products; Quality Manager; Senior Quality Systems Consultant; Director of Regulatory/Quality Systems/Clinical Affairs; Regulatory Coordinator

• Strong Regulatory background in regards to warning letters, recalls, protocol writing, 510(k), PMAs, IDEs, PLAs/ELAs
• Skilled in Quality systems development and deployment; New product development process from R&D to Launch
• International experience working in EU, Canada, Puerto Rico and Mexico; CE Marking and device certification
• ASQ Auditor proficient in Supplier/Contract manufacturer audits
• Experienced Trainer in the areas of GMPs, cGMPs, GLPs, GCPs, QSRs, ISO 9000, 13485, Design Controls, Internal Auditor and Combination Products

CQE with twenty seven years of experience in the Medical Device and Biomedical industries.  In- depth knowledge of Regulations and Standards:  QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).

Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor

• Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
• Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
• Experience in responding to the FDA on 483’s and Warning Letters
• Successfully developed several quality systems for QSR and ISO 13485 compliance
• Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan

Twenty years of regulatory affairs experience in Medical Devices, Pharmaceuticals and
In-Vitro diagnostics.  RAC professional with the ability to efficiently organize and streamline regulatory documentation and procedures.

Titles Held: Regulatory Affairs Manager; Product Standard Release Manager; Quality Control/Technical Service Manager; Director of Technical Services; Clinical Laboratory Supervisor

• Proven track record of successful negotiations and strong working relations with FDA (CDRH) for new product introductions and regulatory compliance issues
• Experience with regulatory strategy, reporting, CAPA processes, recalls and field corrections
• Highly skilled at preparing 510(k)’s and Technical Files for CE marking and liaison with Notified Body
• Knowledge of reviewing and approving product labeling, advertising and promotional materials, specifications, research protocols and reports
• Qualified at managing complaint handling systems and investigating all safety-related incidents

Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&D, Program Management, Quality Systems and Compliance, and Regulatory submissions.

Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer

• Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world
• Experience with warning letters and consent decree situations with both domestic and international firms
• Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products
• Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes
• Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)

Twenty year CQA professional with experience in both Quality Systems and Regulatory Affairs.  Excellent Audit, Validation, Compliance and Design Control background in the Medical Device and Pharmaceutical industries.

Titles Held: Senior Consultant; Director of Quality Assurance; Project Manager

• Excellent international experience: Created several Technical Files and Design Dossiers for the EU, packages for licensing on 6 continents including Canadian License and obtaining Japanese shonin.
• Submittal experience with INDs, IDEs, 510Ks, 510Ks with clinical, PMAs, 1 BLA, 1 HDE, CBE-30s and pre-approval supplements (PAS) for CMC changes to approved products
• QA Validation: Heavy Design Control background; QA review of Testing Protocols and Final Test Reports to assure compliance with applicable standards and regulations
• Strong audit experience with both Internal and External Audits; OEM’s, manufacturers; clinical study sites; sterilization facilities to name a few
• Exceptional Technical Writing skills as well knowledge of Regulations and Guidelines: cGMP, cGCP/ICH, cGLP, QSR, ISO 13485:2003, MDD (all Annexes), HIPAA, 21 CFR Part 11, HACCP, Canadian Regulations, ANSI/AAMI

Computer System Validation expert with twenty-five years experience in the Medical Device and Pharmaceutical regulated environment. Provide definitive compliance technical expertise for Manufacturing; Quality software, hardware and instrument related projects including acting as Subject Matter Expert on 21CFR Part 11.

Titles Held: Senior Validation Consultant; Senior Validation Engineer; Validation Lead; Senior Project Engineer/Validation Engineer; Principal Engineer; Plant Engineer

• Full Validation Life Cycle experience including developing and maintaining Computer System VMPs, Validation Plans, Validation Scripts, and preparing Validation Reports
• Start-ups to remediation projects for pharmaceutical, biotech and medical device companies; experienced in new product launches, FDA 483 Warning Letter Remediation and Consent Decree compliance
• Expert in IQ/OQ/PQ, FDA Compliance, cGMPs Audits, Complaint Reporting Systems, Bar-Code Systems, Vision Systems, PLCs, SOPs, SCADA systems and server-based systems
• Experienced in conducting compliance audits including vendor audits
• Demonstrated success in interviewing organizations to gather understanding of needs and requirements

Biomedical/Manufacturing Quality Engineer with nine years experience in Biomedical Research and Medical Devices. Primary focus is in the area of Quality Assurance, Process Improvement and Design Control.

Titles Held: Quality Engineer; Quality Control Scientist; Biological Chemist

• Skilled at performing Design Failure Modes & Effect Analysis (FMEAs), Process Control, Internal
• Corporate Audits and Risk Assessments
• Test Method Validation, Equipment Validation, DQ, IQ, OQ for New Product Development
• Exposure in launching products in Europe, Japan, Germany, Mexico and Puerto Rico
• Experience with Class III Implant Devices; Class I and II stints, surgical instruments, ENT and Cardio devices
• Working knowledge of governed audits within the FDA, CDC and EPA; strong Biochemist skill set

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

Accomplished RAC professional with substantial regulatory, standards, quality and design assurance expertise.  Thirty years experience in the complex Medical Device and Nuclear Products industry.

Titles Held: Senior Manager of Design Assurance; Director of Design Assurance; Senior Manager of Design Quality Assurance; System Qualification Manager

• Product Development lifecycle, product design compliance to the QSR and MDD, as well as best practices for speed and effectiveness
• Skilled in all areas of Design Assurance such as product risk analysis including software, product design, process validation, process software validation, equipment commissioning and equipment servicing
• Full understanding of ISO 13485, MDD, technical standards, conformance and regulations for EU, Japan and Australia
• Senior Manager experienced with MDR’s and recall decision making as well as product safety
• Face to face experience with FDA and ISO audits the as well as back room support including recovery from Warning Letters