Thirty years of increasing responsibility assuring compliance in the regulated medical device and pharmaceutical industries.  Strong Regulatory submission work and implementation knowledge.

Titles Held: Director of Regulatory Compliance and Quality Systems; Manager of Quality Assurance; Manager of RA/QA; Manager of Quality Control

• Successful submission of four 510(k)’s in a five-month period for Class II devices and one special
• Strong knowledge of auditing practices, regulatory and business requirements including ISO 9001, GMP’s, and international regulations
• Successfully led three organizations through the implementation process and certification process for ISO certification; led multiple organizations to certification for EN 46001:1996, ISO 13485 and EN ISO 9001
• Skilled in all aspects of a regulatory and quality management system for multiple manufacturing sites including design control
• Managed Quality System in multiple sites in the US and Puerto Rico

Senior Manager with thirty-two years of extensive experience in the Medical Device field.  Strong skill set in Quality Assurance and Regulatory Affairs with ASQ and CQM certifications.

Titles Held: Director of QA/RA; Quality & Regulatory Manager; Quality Services Manager; Quality Assurance Manager; Clinical Laboratory Supervisor

• Qualified in Regulatory activities including 510(k) submissions, foreign country product registrations, product device master records, and EU MDD technical file maintenance
• Extensive experience with implementing Quality Systems compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements
• Experience in process and equipment validation including processes in EtO and Gamma Sterilization
• Effectively implemented a plant-wide ISO-9000 certification which resulted in certification by BSI to EN 29001 and EN 46001
• Strong experience with Electromechanical, Mechanical, Electronics, and Capital Equipment

A Medical Device professional with ten years experience in management and development of Quality and Regulatory programs.  Excellent at identifying and resolving issues using systematic analysis and problem-solving skills.

Titles Held: Director of Quality Systems; Manager Quality Control; Manager QA/RA

• Managed ISO/cGMP compliance and coordinated QA/QC activities of a medical device Quality System
• Hands-on experience with Compliance; Process Improvement; Root Cause Analysis, Risk Analysis
• Process Development; Design Control of the DHF & DMR
• Upgraded and managed processes for: Complaints, Corrective and Preventive Action (CAPA), material review board (MRB), product change control (CO), Design History File & Review and supplier quality programs
• Directly involved with FTA, FMECA, DFM reviews, CE conformance reviews, and the design review; ISO 14971, FMEA and risk management plans

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

Nineteen years of experience providing advice, facilitation and training on the development, administration, and technical aspects of quality improvement efforts for the Medical Device industry. Assist clients with compliance needs including FDA/ISO audits, needs assessments, creating quality systems and auditing.

Titles Held: VP of Quality and Compliance; Quality Assurance Manager; Plant Manager

• Due diligence audits, product complaints, Validation/Design control, CAPA’s
• Microbiology/Environmental monitoring; Aseptic processing and calibration
• Facilitation and training on the development, administration and technical aspects of quality improvement efforts for all levels/areas of quality
• Internal and External Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards
• Certified Quality Auditor