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
Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.
Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering
- Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
- Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
- Resolved large backlog of medical device complaints, risk analysis, and investigations
- Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
- Experienced with multi-facility corporate quality assurance and regulatory compliance programs
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
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
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
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
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
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)
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
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
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
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
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
Certified Quality Auditor with twenty-five years of experience. Extensive broad-based knowledge in Quality Assurance with a successful record of introducing and implementing quality systems across multiple locations.
Titles Held: Director of Quality Assurance; Manager of Design Assurance; Manager of Quality Assurance; Senior Project Engineer; Quality Control Engineer
- Vast exposure to Medical Device Regulations including cGMPs and ISO 13485:2003
- Experienced engineer with a passion for new product development; well-versed in submission work as well
- Strong in Design Controls, CAPA’s and Quality Systems implementation
- In-depth knowledge of Class II, disposables, surgical instruments and catheters
- Quality Assurance experience in Europe, Asia, Ireland, China and Germany
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
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
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
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
A highly skilled, International Quality veteran and effective leader with twenty-eight years experience in the Global Quality Movement. Ability to employ a variety of quality methodologies required to support international technical and regulatory requirements.
Titles Held: Senior Consultant; Director of Quality; Quality Manager; General Manager; Project Manager of Reliability; Quality Engineer.
- Extensive experience with implementation, auditing, certification, and maintenance of ISO 13485:2003, ISO 9001:2000, 21CFR820 cGMP, MDD 93/42/EEC, TL, QS, TS, and several other standards
- Expert in international medical device product registrations for global projects from around the world, including: EU CE notified body marking for class II and class III products, China SFDA, Australia TGA , Brazil, Mexico, Canada CMDR / CMDCAS / CAMCAS, Central and South America, Russia device registration and Japan MGLW
- Skilled at creating and updating FMEAs under ISO 14971 risk management, fault trees, Mil-STD-1629, AIAG FMEA, and other risk methods for Hazard Based Safety Engineering
- Experience in the submission of technical files and product dossiers, pre-market notification and device licensing submissions; Canadian Licenses, FDA 510(k) Approvals & PMA Submissions
- Current ASQ certificates, several considered equivalent to a PE license; fluent in Spanish
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 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
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
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
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