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George Calafactor

MEDICAL DEVICE REGULATORY COMPLIANCE SPECIALIST

Midland, PA

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ASQ Certified Biomedical Quality Auditor 
 
MAC/PC Applications, MS Office, Word, Excel, PowerPoint 
 
Additional training includes: Computer Aided Inspections, Computer Systems Validation, FMEA Workshop, Auditing Medical Devices, Medical Device Process Validation, Quality Audits for Improved Performance, Industrial Sterilization for Drugs/Devices, Orientation to International Inspections

Work Experience

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

Regulatory Compliance Associates, Inc.
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Pleasant Prairie, WI
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October 2013 to Present

Responsibilities 
• Provides technical consulting to corporate, legal and government clients.  
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

Validant, Inc.
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San Francisco, CA
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August 2013 to Present

Responsibilities 
• Provides technical consulting to corporate, legal and government clients.  
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

PSC Creative Learning
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Pomona, CA
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June 2013 to Present

Responsibilities 
• Provides technical training & professional consulting to corporate, legal and government clients as a Medical Device Consultant.

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

AUK Technical Services LLC
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Beverly Hills, CA
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June 2013 to Present

Responsibilities 
• Provides technical consulting to corporate, legal and government clients.  
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

FDA Quality and Regulatory Consultants LLC
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Cedar Park, TX
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April 2013 to Present

Responsibilities 
• Provides technical consulting to corporate, legal and government clients.  
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

CONTRACT REGULATORY COMPLIANCE AND QUALITY ASSURANCE CONSULTANT

Pathwise
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American Fork, UT
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May 2012 to Present

Responsibilities 
• Provides technical consulting to corporate, legal and government clients.  
• Provides professional consulting as a Medical Device, Pharmaceutical, and Biologics Quality Systems Consultant.

REGULATORY COMPLIANCE SPECIALIST

Biomet, Inc
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Warsaw, IN
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July 2010 to May 2012

• Conducted mock/internal/external FDA QSR, product, and process audits and investigations of domestic manufacturing facilities of Biomet, including corporate audits of subsidiaries and divisions, within the medical device, pharmaceutical, biologics, tissue realms. 
• Completed quality records and/or prepared written procedures (such as pertaining to document and change control written procedures and CAPA reports) when requested. 
• Headed or assisted with various regulatory compliance and quality projects (such as improving the document and change control and internal audit programs). 
• Evaluated product designs and manufacturing processes for compliance with regulations. 
• Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement. 
• Established continuous process improvement at various levels at the organization. 
• Extensive background in the enforcement of consumer protection regulations. 
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act. 
• Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits. 
• Knowledge of Medical Device Directives, ISO 13485:2003, Canadian Medical Device Regulations, Japanese Medical Device Regulations, and Brazilian Medical Device Regulations. 
• Ensured that manufacturers' employees have proper knowledge of applicable regulations. 
• Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records). 
• Collaborated with site manufacturing personnel to gather information and explain findings. 
• Advised firm officials on FDA enforcement policies. 
• Conducted training sessions on quality, medical device regulations, FD&C law, inspection and investigation techniques and other related topics. 
• Communicated with and maintained customer relations with facility personnel (such as during internal audits of other site locations). 
• Significant experience in making group presentations to firm personnel.

CONTRACT MEDICAL DEVICE QUALITY EXPERT

Pan America Hyperbarics, Inc
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May 2009 to February 2010

• Conducts gap analysis of quality system using FDA laws and regulations. 
• Assists with the development of quality control procedures and SOPs as required. 
• Provides regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments. 
• Conducts training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments. 
• Conducts internal audits of the quality system. 
• Prepares written audit correction plan. 
• Performs various audit correction activities, including revising written instructions, revamping the document and change control, purchasing control, CAPA, and production and process control operations.

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE EXPERT

The FDA Group
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2010 to January 2010

January 2010 • Conducts gap analysis of quality system using FDA laws and regulations. 
• Assists with the development of quality control procedures and SOPs as required. 
• Provides regulatory, quality, and technical expertise to the top management and quality, engineering/R&D, and production departments. 
• Conducts training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality, engineering/R&D, and production departments. 
• Conducts internal audits of the quality system. 
Initial Importer/ Distributor and Contract Medical Device Manufacturer (Installer and 
Servicer): Pan America Hyperbarics, Inc. Richardson, TX 
December 2009 • Conducts gap analysis of quality system using FDA laws and regulations. 
• Assists with the development of quality control procedures and SOPs as required. 
• Provides regulatory, quality, and technical expertise to the top management and quality, and installation/ servicing departments. 
• Conducts training sessions related to regulatory, compliance, quality, and auditing to top management, and to the quality and installation/ servicing departments. 
• Conducts internal audits of the quality system. 
Pharmaceutical, Biologic, and Medical Device Specification Developer: Healthpoint, Ltd., Fort  
Worth, TX

CONTRACT MEDICAL DEVICE QUALITY EXPERT

The FDA Group
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March 2009 to January 2010

• Provides technical consulting to corporate, legal and government clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant. 
Device Manufacturer: Thermo Fisher Scientific, Middletown, MA 
March 2010 • Provide guidance of off label requirements using FDA laws and regulations.

CONTRACT MEDICAL DEVICE QUALITY EXPERT

Gerson Lehrman Group
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New York, NY
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November 2009 to December 2009

• Provides technical consulting to corporate, legal and government clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant. 
Medical Device Client: Miura Global Management, LLC, New York, NY 
November 2009 • Analyze business, legal, quality, sterilization and non-conformance data associated with orthopedic implant MDR claims made by another orthopedic implant competitor.

CONTRACT MEDICAL DEVICE QUALITY EXPERT

Orchid Design
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Shelton, CT
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2009 to December 2009

• Provides technical consulting to corporate, legal and government clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant.  
Medical Device Client: Mini-Lap Technologies, Inc. Dobbs Ferry, NY

CONTRACT MEDICAL DEVICE QUALITY EXPERT/ QUALITY CONSULTANT

Engineering Resource Group
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Morris Plains, NJ
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May 2009 to August 2009

• Provides various quality compliance consulting and contracting to corporate, clients.

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE EXPERT

Engineering Resource Group
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Passaic, NJ
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May 2009 to August 2009

• Conducts gap analysis of quality system using FDA and EU laws, standards, and regulations. 
• Assists with the development of quality control procedures and SOPs as required. 
• Ensures product development follows appropriate design control requirements. 
• Provides regulatory, quality, and technical expertise to the engineering, quality, and production departments. 
• Conducts training sessions related to regulatory, compliance, quality, and auditing for top management, and to the engineering, quality, and production departments. 
• Conducts internal audits of the quality system. 
• Develops various regulatory, quality and compliance logs and spreadsheets. 
• Assists the quality engineer in various quality compliance activities, as needed.

CONTRACT MEDICAL DEVICE CONSULTANT/ REGULATORY SPECIALIST

Aerotek Scientific, LLC
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Piscataway, NJ
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June 2008 to February 2009

• Provides various quality compliance consulting and contracting to corporate, clients.

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE EXPERT

Aerotek Scientific, LLC
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Hackensack, NJ
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June 2008 to February 2009

• Conduct mock/internal/external FDA/ISO/MDD QSR audits of domestic manufacturing facilities within the medical device realm. 
• Process Audits and Analysis 
• Provide technical support, and regulations and standards support to the audit team 
• Perform in-depth process audits, as required 
• Ensure corrective actions are effective in addressing the root cause to help prevent the recurrence of non-conformities 
• Perform statistical analysis such as process capability, trend analysis and process control 
• Issue, as required, corrective action and preventive action on the processes 
• Complete technical reviews and analyses of nonconformities, corrective actions and preventive actions (CAPA's), and complaints as required. Prepare CAPA analyses and issue corresponding CAPA's. 
• Function as the back-up to the QA/RA Manager for review and approval purposes 
• Maintains technical files and risk management files for all devices and pharmaceuticals. Responsible for organizing and scheduling periodic risk management reviews. 
• Responsible for filing product registration applications and handling government interactions pertaining to the regulation process for registering products in the EU, Japan, Australia and Canada, when requested. 
• Interface with customers, regulatory bodies (FDA, TUV, Health Canada) as required. 
• Review, analyze, and communicate the effectiveness of Corrective and Preventive actions. 
• Review and provide QA technical support of ECN's. 
• Review label content for regulatory requirements 
• Review and approve manufacturing instructions, product and packaging specifications and provide technical assistance. 
• Promote and support continuous improvement initiatives. 
• Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements.

CONTRACT MEDICAL DEVICE QUALITY EXPERT

Aerotek Scientific, LLC
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Minneapolis, MN
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July 2008 to November 2008

• Provides technical consulting to corporate, legal and government clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant, Governmental Registration Process Consultant, International Business Consultant, GMP Consultant. 
• Can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support, forensic services, and related expert witness services in litigation areas as a FDA Medical Device Quality Systems, Governmental Registration, International Business, and GMP's. 
• Serves as a resource to Intota Market Research Services for customized marketing research in industries or areas related to FDA Medical Device Quality Systems, Governmental Registration Process, International Business, and GMP. 
Law Office (Confidential), Scherrillville, IN July 2008 
• Analyze, investigate, and review associated documentation, labeling, and potential non-conforming combination pharmaceutical and medical device products. 
• Case settled due to my expertise.

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE EXPERT

Aerotek Scientific, LLC
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July 2008 to November 2008

• Analyze, investigate, and review depositions and associated MDR/ complaint, et al documentation pertaining to a potential non-conforming surgical medical device product. 
• Case settled due to my expertise.

REGULATORY COMPLIANCE AUDITOR

Synthes, USA
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West Chester, PA
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January 2008 to April 2008

• Conducted mock/internal/external FDA QSR audits of domestic and foreign manufacturing facilities of Synthes, including supplier audits, within the medical device realm. 
• Completed quality records and/or prepare written procedures (such as pertaining to CAPA validation/verification of effectiveness reports) when requested. 
• Evaluated product designs and manufacturing processes for compliance with regulations. 
• Performed onsite reviews of firm written procedures, processes, and operations and where necessary, recommended corrections for continuous improvement. 
• Established continuous process improvement at various levels at the organization. 
• Extensive background in the enforcement of consumer protection regulations. 
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act. 
• Experience in both the FDA field and headquarters offices to ensure compliance prior to FDA inspectional visits. 
• Ensured that manufacturers' employees have proper knowledge of applicable regulations. 
• Developed and implemented business practices improving and reducing operating expenses of company sites (such as aiding in the creation of new device master records). 
• Collaborated with site manufacturing personnel to gather information and explain findings. 
• Advised firm officials on FDA enforcement policies. 
• Conducted training sessions on inspection and investigation techniques and other related topics. 
• Communicated with and maintained customer relations with facility personnel (such as during internal audits of other site locations). 
• Significant experience in making group presentations to firm personnel.

CONTRACT MEDICAL DEVICE QUALITY CONSULTANT

Oxford International
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Beverly, MA
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November 2007 to December 2007

• Provides technical consulting to corporate clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant.

CONTRACT MEDICAL DEVICE REGULATORY COMPLIANCE EXPERT

Oxford International
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Austin, TX
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November 2007 to December 2007

• Compile data necessary to complete 21 CFR 803 MDR baseline reports. 
• Report to Quality and Regulatory management on bringing the MDR processes and product 510(k)/PMA files into FDA compliance for various class I/III orthopedic implants and accessories.

INTERNATIONAL MEDICAL DEVICE CONSULTANT

New World Regulatory Solutions, Inc
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August 2007 to November 2007

• Provides technical consulting to corporate clients. 
• Provides professional consulting as a FDA Medical Device Quality Systems Consultant. 
In-vitro Diagnostic Medical Device Manufacturer- Oxford Innumotec, LLC,

Analyst/ Level II Certified International Medical Device Investigator

US Food and Drug Administration
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Chicago, IL
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January 1985 to February 2006

IL/ Pittsburgh, PA/ South Bend, IN 
ANALYST/LEVEL II CERTIFIED INTERNATIONAL MEDICAL DEVICE INVESTIGATOR 
• Conducted routine inspections of domestic and foreign manufacturing facilities and investigated consumer complaints related to FDA-regulated products, primarily within the medical device industry. 
• Conducted full foreign medical device inspections for over 10 years at sites manufacturing all classes and types of medical devices and located throughout Canada and Europe. 
• Evaluated product designs and manufacturing processes for compliance with regulations. 
• Performed and documented numerous inspections, achieving enhanced compliance through various regulatory actions including warning letters and seizures. 
• Established continuous process improvement at all levels in organization. 
• Extensive background in the enforcement of consumer protection regulations. 
• Thorough knowledge of all provisions of the Federal Food, Drug, and Cosmetic Act. 
• Experience in both the field ensuring FDA compliance as well as in the headquarters office. 
• Worked (internal detail positions) as a field compliance officer, FDA HQ international medical device inspection planner, and FDA HQ International compliance officer. 
• Ensured that manufacturers' employees have proper knowledge of applicable regulations. 
• Developed and implemented business practices improving and reducing operating expenses. 
• Collaborated with manufacturers' personnel to gather information and explain findings. 
• Initiated legal actions against violators. 
• Advised industry, state, and local officials and consumers on enforcement policies. 
• Conducted training sessions on inspection and investigation techniques and other related topics. 
• Communicated with and maintained customer relations 
• Served as team leader on complex assignments requiring the participation of multiple personnel. 
• Fulfilled the duties of the Resident-In-Charge during an extended period of absence. 
• Significant experience in making group presentations. 
• Demonstrated skills in preparing comprehensive and easily understood written communications. 
• Fostered team spirit and open communication on all phases of business. 
• Developed approaches and procedures which have improved the efficiency of agency operations. 
• Level I/II Certified International Medical Device Investigator.

Education

MBA in International Business

Indiana University -
South Bend, IN

January 1991 to January 1999

BS in Metallurgical Engineering

University of Notre Dame -
Notre Dame, IN

January 1984 to January 1989

BS in Chemistry

University of Notre Dame -
Notre Dame, IN

January 1978 to January 1982

Skills

Medical Device Regulatory Compliance Auditing

Additional Information

SKILLS 
• Audit, review, and critique most lean related manufacturing technologies. 
• Skilled in quality and business concepts, including quality systems and international business management. 
• Revise, prepare, audit, review and critique QA and QC programs and documentation to ensure quality production. 
• Provide QA Mfg and test support for Mfg floor and contract vendor production lines. 
• Provide information and support for ongoing product design and new product design review boards. 
• Audit, review and critique all QSM, SOP, EC related protocols and documentation. 
• Audit, review and critique all IQ, OQ, PQ, PPQ related protocols and documentation. 
• Audit, review and critique all QC Mfg related protocols and documentation. 
• Audit, review and critique Risk Management program and deliverables (FMEA's, FTA's, etc). 
• Audit, review and critique manufacturing program procedures, sampling, and processes. 
• Participate and represent Regulatory in Design and Manufacturing meetings. ECO, DRB, MRB, etc. 
• Knowledgeable in FDA, Health Canada, EU, Brazilian, and Japanese medical device regulations. 
• Train and Qualify QA, Mfg, Test and Admin personnel related to the manufacturing and test processes. 
• Work with ISO/EN/CE, FDA, Health Canada, and other Agency documentation and Qualifications. 
• Revise, prepare, audit, review and critique Multi-level SOP, BOM, and ECO process instructions and records. 
• Audit, review and critique SPC and QC/QA related protocol and documentation. 
• Skilled in New Product Introduction, (NPI) and CE mark certification processes. 
• Audit, review and critique validation SOPs and policies according to cGMPs for aseptic process validation, sterilization validation (steam, gamma, EtO, dry heat, etc.). 
• Audit, review and critique large and small subsidiaries and vendors for set-up and transfer of products to headquarters and vendor sites. 
• Audit, review and critique schematics, blueprints and build instructions for various medical devices, including in-vitro diagnostics, orthopedic, electrical and mechanical devices. 
• Proficient in MAC/PC Applications: MS Windows, MS Office, Word, Excel, PowerPoint, etc. 
• Audit, review and critique purchasing control records and operations 
• Audit, review and critique Software and Hardware validation. 
• Audit, review and critique Failure mode effect analysis of product design specifications and documentation. 
• Monitor, maintain, audit, review and critique Corrective action and process document processes. 
• Audit, review and critique Design review FMEAs and risk management for product design analysis. 
• Audit all major test equipment (such as scopes, logic analyzers, spectrum analyzers, etc.). 
• Audit all major production equipment (such as CNC machines, packaging machines, sterilizers, etc.). 
 
REGULATORY EXPERTISE 
All Types of Class I/III Medical Devices, Including Electronic, Mechanical, and Non-mechanical Medical Devices- Durable, Electronics, Implantables, IVDs, Lasers, Software, Cataract systems, Oncology systems, Coated Stents, Steerable Catheters, Over the wire (OTH), Rapid Exchange (RX) Stent delivery systems (STS), Pacemakers, Tracheostomy Tubes, Sterilized Devices, and Orthopedic Implants. Adverse Event Evaluation, Audits -Certification/Due Diligence/ GCP/ GLP / ISO/Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Clinical Labeling / Research/ Study design, Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA, FDA - 483 and Warning Letter Responses/Consent Decree, GMP, Hazard Analysis, ISO - 13485/ 9001/9002/ 9003/14971 (Risk Management)/ Active Implantable Medical Device Directive (AIMD) / In-vitro Diagnostic Directive/ Medical Device Directive (MDD), OSHA, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Working Knowledge of FDA Operations. 
 
HIGHLIGHTS OF QUALIFICATIONS 
• Medical Device Compliance • Results Oriented • Problem Resolution 
• Failure Modes & Effects Analysis • Strong Negotiation Skills • Strategic Planning 
• Excellent Communication Skills • Team Player and Leader • Project Management