Joseph C. Griffin, Iii

Joseph C. Griffin, Iii Email and Phone Number

Managing Director, Owner @ Regletics, LLC
Moorestown, NJ, US
Joseph C. Griffin, Iii's Location
Moorestown, New Jersey, United States, United States
Joseph C. Griffin, Iii's Contact Details

Joseph C. Griffin, Iii personal email

Joseph C. Griffin, Iii phone numbers

About Joseph C. Griffin, Iii

• 40+ years' experience in design, development, manufacture, clinical trial, regulatory approval and compliance of Class II and Class III disposable and implantable cardiovascular / vascular devices. • Proven fiscal responsibility and budget management.• Inventor and co-inventor of 15 medical device related US Patents.• Executive team member in start-up, growth and acquisition of Vesper Medical, Inc. by Royal Philips. • Executive team member in start-up, growth and acquisition of Intact Vascular, Inc. by Royal Philips.• Executive team member in start-up, growth and acquisition of Flexible Stenting Solutions by Cordis Corporation, a Johnson & Johnson Company.• Founder of Professional Catheter Corporation, the predecessor to ProCath Corporation, as named upon acquisition by EP MedSystems, Inc. (St. Jude) and operated entity as a wholly owned subsidiary.• Key management team member in start-up, rapid growth and acquisition of Nova Medical Specialties, Inc. by B. Braun of America.• Resourceful problem solver and crisis manager. • Eager to seek out, learn and embrace new ideas and technologies.• Dedicated, loyal, Company team builder.• Leader and motivator with substantial hands-on organizational development experience. • Exploit strengths by building teams with expertise in areas of weakness.• My business philosophy and core values have enabled me to succeed and inspired others to do the same.Specialties: • Executive Level Strategic Planning & Execution• Mergers and Acquisitions• Corporate Compliance, Policy / Ethics• Organization Building • Raising Capital / Funding Growth• Sales & Marketing• Regulatory Affairs, Quality Assurance & Clinical Trial Expertise• New Venture Start-up• Product Development• Technology Transfer / Mergers & Acquisitions• Research & Development – Exploit & develop New Technologies• Intellectual Property Management & Trademarks• Manufacturing, Packaging & Sterilization Expertise• Device Microbiology & Biocompatibility

Joseph C. Griffin, Iii's Current Company Details
Regletics, LLC

Regletics, Llc

View
Managing Director, Owner
Moorestown, NJ, US
Joseph C. Griffin, Iii Work Experience Details
  • Regletics, Llc
    Managing Director, Owner
    Regletics, Llc
    Moorestown, Nj, Us
  • Vesper Medical, Inc. (A Philips Owned Company)
    Compliance Officer - Vice President Regulatory Affairs And Quality Assurance
    Vesper Medical, Inc. (A Philips Owned Company) Oct 2016 - Present
    Vesper Medical, Inc. was acquired by Royal Philips on January 11, 2022. U.S. FDA PMA regulatory approval for the Vesper Duo Venous Stent System received on 12-26-23. PMA No. P230021. Device System, consisting of a Hybrid stent and an Extend stent, is approved for sale in the U.S. Hybrid Stent portion of the system CE Mark authorized under the MDD. Full Duo Venous Stent System EU MDR CE Mark authorization application currently under Notified Body review.Learn more at www.vespermedical.com
  • Dematteo Monness Llc
    Advisor - Medical Device Industry Professional
    Dematteo Monness Llc Apr 2010 - Present
    New York, Us
    As an Advisor in the DM Consultant Network, I provide global Medical Device industry expertise to DM clients who include institutional investors and professional asset managers in the hedge fund, mutual fund, and private equity arenas. This is an important part of DM clients' investment due diligence process where I provided my views on relevant industry themes and trends, and lend my insight based on my 40+ year’s experience.Important Note: Clients that present "Conflict of Interest" issues with an Employer are not accepted. All "Non-Disclosure" agreements are strictly observed. Protection of confidential information is always paramount and assured. All information provided is done so in observance of SEC enforced regulations and the DM "Code of Ethics".
    View
  • Guidepoint Global Advisors
    Advisor - Medical Device Industry Professional
    Guidepoint Global Advisors Jan 2009 - Present
    New York, Ny, Us
    Guidepoint Global Advisors is an exclusive network of academic and industry professionals who consult to business decision-makers and leading investors around the world. Important Note: Clients that present "Conflict of Interest" issues with an Employer are not accepted. All "Non-Disclosure" agreements are strictly observed. Protection of confidential information is always paramount and assured. All information provided is done so in observance of SEC enforced regulations.
    View
  • Intact Vascular, Inc.
    Compliance Officer - Vice President, Regulatory Affairs And Quality Assurance
    Intact Vascular, Inc. Jan 2014 - Sep 2020
    Wayne, Pennsylvania, Us
    Successful exit from this role - Intact Vascular, Inc. acquired by Philips August 2020 - $275 million upfront plus future earnouts. Obtained U.S. FDA regulatory PMA approval for Intact Vascular's above-the-knee (ATK) " Tack Endovascular System (6F)" indicated for post-PTA dissection repair in the superficial femoral and proximal popliteal arteries - PMA No. P180034. Obtained U.S. FDA PMA approval for Intact Vascular's below-the-knee (BTK) "Tack Endovascular System (4F)" indicated for post-PTA Dissection Repair in distal popliteal, peroneal and tibial arteries - PMA No. P190027. This device is the first BTK permanent vascular implant to be approved by FDA. Both ATK and BTK devices are CE Mark authorized for distribution in Europe and Countries that recognize CE Mark.Learn more at www.intactvascular.com
    View
  • Burpee Materials Technology, Llc
    Vice President Regulatory Affairs (Consultant To Cordis Corporation)
    Burpee Materials Technology, Llc "Cordis / Johnson & Johnson Contractor" Mar 2013 - Dec 2013
    Flexible Stenting Solutions was acquired by Cordis Corporation, a Johnson & Johnson Company, on 3-8-13. I joined Burpee Materials Technology, a major shareholder in Flexible Stenting Solutions, on 3-11-13 to support the transition to Cordis by acting as Vice President of Regulatory Affairs as a consultant.
  • Flexible Stenting Solutions, Inc.
    Vice President, Regulatory & Clinical Affairs
    Flexible Stenting Solutions, Inc. Jul 2012 - Mar 2013
    Flexible Stenting Solutions was acquired by Cordis Corporation, a Johnson & Johnson Company, on 3-8-13. Position change from VP, RA / QA to VP, RA / CA. Promoted Quality Manager to Quality Director who assumed my QA responsibility.
  • Flexible Stenting Solutions, Inc.
    Chief Compliance Officer
    Flexible Stenting Solutions, Inc. Apr 2011 - Mar 2013
    Flexible Stenting Solutions acquired by Cordis Corporation, a Johnson & Johnson Co., on 3-8-13. • Developed a Corporate Compliance Program addressing, False Claims Act, Civil Money Penalties Law (CMP), Stark Law, Anti-Kickback Statute, HIPPA, etc. • Established a Corporate Compliance Board• Drafted a Corporate Compliance Board Charter• Created compliance related procedures for training, monitoring, auditing and reporting.• Created comprehensive training materials and conducted stakeholder training sessions.• Adopted the AdvaMed Code of Ethics.• Executed enforcement of SOPs.
  • Flexible Stenting Solutions, Inc.
    Vice President, Ra / Qa
    Flexible Stenting Solutions, Inc. Mar 2008 - Mar 2013
    Flexible Stenting Solutions was acquired by Cordis Corporation, a Johnson & Johnson Company, on 3-8-13. • Provided International Sales and Marketing expertise • Provided Product and Regulatory Compliance training to International Distributors. • Closed multi-million dollar deal with major Japanese Medical Device Company w/ CEO• Ensure Domestic and International Medical Device regulatory compliance.• Official FDA and EU Notified Body correspondent.• Obtained FDA IDE Approval for SFA Popliteal Stent Products• Obtained several FDA 510(k) clearances for Biliary Stent Products• Direct FDA QSIT, cGMP, ISO Quality System and Design Control auditing, implementation and corrective action. Chair of Material Review Board.• Prepared FDA 510(k) and IDE submissions. • Responsible for Clinical Trial monitoring and PMA preparation and submission.• Obtained full scope ISO 13485 Quality System Certification and CE Marking under MDD 93/42/EEC Annex II Full Quality Assurance.• Obtained CE Mark Authorization for SFA/Pop and Biliary Stent Products.• Process Verification and Validation oversight and direction for compliance.• Specified and provided oversight for construction of a new Class 10,000 cleanroom.• Provided Clinical Trial oversight for clinical investigations completed in New Zealand and Germany.
  • Joseph Charles & Company, Llc
    Managing Director, Owner
    Joseph Charles & Company, Llc Jun 2000 - Feb 2012
    Regulatory Affairs, Quality Assurance, Product Developement and Manufacturing Consultants to the Medical Device Industry. • Provide Manufacturing and Regulatory Affairs expertise.• Conduct FDA and EU Notified Body negotiations and communications.• Perform FDA QSIT, cGMP, ISO Quality System and Design Control auditing, implementation and corrective action.• FDA IDE submissions and Clinical Trial support.• FDA 510(k) submissions and FDA review support.• FDA PMA submissions and FDA review support.• ISO 13485 Quality Management Systems and CE Marking.• Product and Process Verification and Validation.• Operate In-house machine shop in conjunction with machine design and fabrication for product testing and manufacturing automation.• Perform product design for manufacturing analysis, including material cost, methods time management and scrap reduction.• Detect gaps between new product development, transfer to manufacturing and regulatory compliance and provide corrective action plan. • Upon retirement from EP MedSystems, Inc., retained by the Company as a Consultant. At the same time, formed Joseph Charles and Company to remain active and keep current with the ever changing Medical Device market.
  • Ep Medsystems, Inc.
    Vice President, Regulatory Affairs
    Ep Medsystems, Inc. Nov 1993 - Jun 2000
    St. Paul, Minnesota, Us
    • Obtained ISO 9001 and EN46001 Quality System Certification for the Company and product CE Marking for all of its class II and class III devices including the compilation of design dossiers.• Prepared and filed a Modular PMA Class III device submission with the FDA for the Company’s ALERT® catheter system for treating patients with Atrial Fibrillation. PMA approval No. P990069• Obtained numerous FDA 510(k) notification clearances for new class II products.• Specified, reviewed and approved microbiological, biocompatibility and sterility testing.• Provided intellectual property, catheter technology and regulatory compliance expertise for the preparation of SEC form SB-2/A for registration of EP MedSystems securities and IPO prospectus in June 1996 and continued review of same for its 10-QSB and 10-KSB filings.• Interfaced directly with Physicians in the development of new device technologies such as the Company’s ALERT® catheter system and instrumental in the design for manufacture of this multi-electrode catheter and many other innovative devices.• Inventor and co-inventor of 13 US Patents for novel catheter designs and methods of manufacture and assigned them to the Company.
    View
  • Ep Medsystems, Inc.
    President Of Procath Corp. (Wholly Owned Subsidiary Of Ep Medsystems)
    Ep Medsystems, Inc. Nov 1993 - Jun 2000
    St. Paul, Minnesota, Us
    • Directed and managed a class 10,000 cleanroom catheter manufacturing operation. Expanded cleanroom operation from 2,500 to 15,000 sq. ft. in six months. Increased catheter production output by 500%.• Obtained ISO 9001 and EN46001 Quality System Certification for the Company and product CE Marking for all of its class II and class III devices including the compilation of design dossiers.• Prepared and filed a Modular PMA Class III device submission with the FDA for the Company’s ALERT® catheter system for treating patients with Atrial Fibrillation. PMA approval No. P990069• Obtained numerous FDA 510(k) notification clearances for new class II products.• Specified, reviewed and approved microbiological, biocompatibility and sterility testing.• Provided intellectual property, catheter technology and regulatory compliance expertise for the preparation of SEC form SB-2/A for registration of EP MedSystems securities and IPO prospectus in June 1996 and continued review of same for its 10-QSB and 10-KSB filings.• Interfaced directly with Physicians in the development of new device technologies such as the Company’s ALERT® catheter system and instrumental in the design for manufacture of this multi-electrode catheter and many other innovative devices.• Inventor and co-inventor of 13 US Patents for novel catheter designs and methods of manufacture and assigned them to the Company.
    View
  • Cooper Run Executive Park Condo. Assoc.
    Chairman / President
    Cooper Run Executive Park Condo. Assoc. 1997 - 2000
    Operated 30 Unit x 100,000 sq. ft. light manufacturing and office Condominium complex. Successfully mediated Owner disputes and resolved all problems. Conducted board meetings, reviewed and approved all expenditures. Directed retained tax account and legal counsel. Responsible for ensuring Owner compliance and maintenance of Master Deed common elements. Forcast and budget fee assessments for long term maintenance of common property elements.
  • Professional Catheter Corporation
    Ceo, President And Founder
    Professional Catheter Corporation Jun 1990 - Nov 1993
    • Specified and built from ground up a class 10,000 cleanroom for catheter manufacturing and packaging in leased warehouse space.• Designed and specified all catheter raw materials for EtO sterilization including packaging and labeling. Sourced and qualified all raw material vendors and validated sterilization process.• Built an administrative and engineering staff. Hired and trained manufacturing personnel.• Designed and manufactured temporary pacing and electrophysiology catheter product lines. • Developed marketing strategy and private label catheter sales including kitting and packaging introducers, dilators and needles used for catheter insertion. • Prepared all regulatory submissions and obtained numerous FDA 510(k) notification clearances for new class II products.
  • Oscor Medical Corporation
    Research & Development Director And Pacing Lead Manufacturing Mgr.
    Oscor Medical Corporation 1989 - 1990
    • Transferred new pacing lead manufacturing technology from Dr. Osypka, GmbH., Germany.• Sourced and qualified new US based vendors for critical pacing lead components eliminating import costs from Germany.• Converted 12,000 sq. ft. of non-functional facility space into class 10,000 assembly cleanrooms.• Increased pacing lead manufacturing by 45% over a one year period.• Reduced final product quality rejections by implementing stringent class 1,000 cleanroom guidelines for all critical component assembly.• Improved manufacturing productivity through job analysis and reorganization.• Established a fully integrated in-house research and development machine shop.• Resigned from company and started Professional Catheter Corporation when promises of new product development opportunities “as a condition of employment” were never realized.
  • Nova Medical Specialties, Inc. Div. Of B. Braun America
    Director Of Research & Development And Technical Services
    Nova Medical Specialties, Inc. Div. Of B. Braun America 1982 - 1989
    Bethlehem, Pa, Us
    • Designed, developed and patented a disposable pressure transducer tipped catheter which eliminated the need for external pressure transducers that are subject to numerous errors.• Developed and patented the first dual-thermistor thermodilution catheter in the industry. Design eliminated the need for correction factors and controlled injection bolus temp thus simplifying cardiac output measurements and reducing fluid input in patients with pulmonary edema.• Obtained numerous FDA 510(k) clearances for new Class II catheter products.• Developed the first blood compatible aliphatic polyurethane balloon catheter in the industry which increased thermodilution sales 100% over a one year period and reduced thrombo-embolism risk to patients. • Developed an in-house benzalkonium chloride complex process for heparin coating catheters to reduce thrombosis which resulted in immediate sales increase.• Designed and developed A-V O2 differential and O2 saturation fiber optic catheters for Picker International through Hospex.• Designed and developed water cooled laser guiding catheters for Cooper Laser Sonics.• Designed and developed gallstone removal catheters and renal stents for Millrose Labs.• Increased catheter profit margins with the development and utilization of in-house insert injection molding of catheter part assemblies.• Developed a gas plasma process to alter the surface characteristics of latex balloons and other catheter raw materials for improved bonding adhesion and blood compatibility.• Designed and implemented computerized parts cataloging and inventory data retrieval system.• Developed a documentation system to monitor production efficiency, trace raw material lot history and provide real-time direct labor costs for all manufacturing and packaging operations.• Developed special PA wedge pressure, angiographic, embolectomy, and other balloon catheters.
    View
  • American Catheter Corporation (Johnson And Johnson Owned Subsidiary)
    Design Drafter / Jr. Engineer
    American Catheter Corporation (Johnson And Johnson Owned Subsidiary) 1978 - 1982
    Us
    • Team member in the integration of catheter technologies during acquisition of American Catheter Corporation initially by Extracorporeal division of J&J and subsequent internal J&J acquisitions by Handcock Labs, Vascor and finally Critikon.• Designed and drafted from conception to production cardiovascular balloon catheters and related component parts. • Provided regular classroom instruction to all manufacturing personnel on the proper interpretation of engineering specifications and product assembly drawings.• Learned FDA GMP requirements from J&J experts and generated necessary documentation and systems bringing our division into corporate policy compliance.• Established an OSHA required material safety data system for employee access.
    View
  • Inductotherm Corp.
    Mechanical Drafter
    Inductotherm Corp. 1977 - 1978
    • Created isometric conceptual product drawings. Produced electrical schematics, hydraulic schematics, cooling water schematics and mechanical assembly drawings for mega sized induction melting furnaces for the largest foundry companies worldwide. Traveled with the Company pilot / head engineer, in the Company plane to remote foundry locations to perform field surveys for equipment we would build for them. The Company Owner and Mentor, the late Henry Rowan donated $200 million to Glassboro State College which was renamed in his honor to Rowan University.

Joseph C. Griffin, Iii Skills

Medical Devices Fda Regulatory Affairs Quality System Product Development Clinical Research Healthcare Start Ups Clinical Trials R&d Validation Iso 13485 Technology Transfer Gmp Venture Capital Quality Assurance Design Control Biotechnology Manufacturing Commercialization Product Launch Cross Functional Team Leadership Product Management Mergers And Acquisitions Business Development Mergers Patents International Business Regulatory Submissions Strategy Entrepreneurship Leadership Strategic Planning Executive Management Management Lifesciences Process Improvement V&v Product Marketing Project Management Strategic Partnerships Competitive Analysis Market Analysis Process Simulation Capa Corporate Compliance Gcp Glp Fmea 93/42/eec Medical Device Directive

Joseph C. Griffin, Iii Education Details

  • Caliso Tüv Usa - Iso 13485 Auditor
    Caliso Tüv Usa - Iso 13485 Auditor
    Iso 13485 Auditor - Medical Devices
  • Tufts New England Medical Center - Technomic
    Tufts New England Medical Center - Technomic
    Advanced Medical Plastics
  • Society Of Manufacturing Engineers
    Society Of Manufacturing Engineers
    Medical Plastics Technology
  • University Of Lowell - Tufts New England Medical Center
    University Of Lowell - Tufts New England Medical Center
    Silicones & Polyurethanes For Medical Applications
  • Rutgers University - Camden
    Rutgers University - Camden
    Youth Sports Coach
  • Rowan College At Burlington County
    Rowan College At Burlington County
    Engineering
  • American Red Cross
    American Red Cross
    First Aid And Cpr
  • Maple Shade High School
    Maple Shade High School

Frequently Asked Questions about Joseph C. Griffin, Iii

What company does Joseph C. Griffin, Iii work for?

Joseph C. Griffin, Iii works for Regletics, Llc

What is Joseph C. Griffin, Iii's role at the current company?

Joseph C. Griffin, Iii's current role is Managing Director, Owner.

What is Joseph C. Griffin, Iii's email address?

Joseph C. Griffin, Iii's email address is jg****@****ail.com

What is Joseph C. Griffin, Iii's direct phone number?

Joseph C. Griffin, Iii's direct phone number is +148425*****

What schools did Joseph C. Griffin, Iii attend?

Joseph C. Griffin, Iii attended Caliso Tüv Usa - Iso 13485 Auditor, Tufts New England Medical Center - Technomic, Society Of Manufacturing Engineers, University Of Lowell - Tufts New England Medical Center, Rutgers University - Camden, Rowan College At Burlington County, American Red Cross, Maple Shade High School.

What are some of Joseph C. Griffin, Iii's interests?

Joseph C. Griffin, Iii has interest in Bambini, Boating, Children, Construction, Science, Family First, Technology And History, Landscaping, Offshore Saltwater Fishing, Golf.

What skills is Joseph C. Griffin, Iii known for?

Joseph C. Griffin, Iii has skills like Medical Devices, Fda, Regulatory Affairs, Quality System, Product Development, Clinical Research, Healthcare, Start Ups, Clinical Trials, R&d, Validation, Iso 13485.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.