Vice President Quality & Regulatory Affairs @ Topcon America Corporation
VP Regulatory, Quality and Clincial Affairs @ Optovue
Bachelors in Engineering, Electrical, Mechanical @
Stevens Institute of Technology
Bio, John J. Talarico
John Talarico, VP of Quality Clinical and Regulatory Affairs, spearheaded his Company’s regulatory, clinical and quality commitment and efforts in procuring international regulatory approvals. John's expertise ranges from the lifting of FDA warning letters, gaining PMAs, 510(k)s, INDs, 505(b)2, and IDE approvals as well as other international product approvals (FDA, CE and other
Bio, John J. Talarico
John Talarico, VP of Quality Clinical and Regulatory Affairs, spearheaded his Company’s regulatory, clinical and quality commitment and efforts in procuring international regulatory approvals. John's expertise ranges from the lifting of FDA warning letters, gaining PMAs, 510(k)s, INDs, 505(b)2, and IDE approvals as well as other international product approvals (FDA, CE and other non-EU countries).
John has over 25 years of extensive medical device experience in the areas of Quality, Clinical and Regulatory Affairs, working for companies such as Johnson & Johnson, Honeywell Medical and Bell Labs. John has a Bachelor’s of Engineering Degree from Stevens Institute of Technology, and received his Masters Degree in Business Administration from Florida Institute of Technology.
Vice President Quality & Regulatory Affairs @ Corporate America VP, responsible for:
- spearheading all Regulatory Affairs activities as it relates to the company's medical products.
- instituting Regulatory and Quality Assurance compliance on both the local and international level for all products.
- strategic Consulting, including business plan & regulatory strategy development to support sales and marketing From August 2012 to Present (3 years 5 months) VP Regulatory, Quality and Clincial Affairs @ John joined Optovue, Inc, Inc in 2010 to spearhead the Company’s regulatory, clinical and quality commitment. His expertise is in regulatory cGXP & ISO compliance, PMAs, 510(k)s, INDs, 505(b)2, and IDE as well as FDA, CE and other non-EU countries. John has over 25 years of medical device experience in Quality, Clinical and Regulatory Affairs. From May 2010 to October 2012 (2 years 6 months) Sr. VP Quality Systems and Regulatory Affairs @ John Talarico, Sr. VP of Quality Systems and Regulatory Affairs, joined Delcath, Corp, Inc in 2008 to spearhead the Company’s regulatory, clinical and quality commitment and efforts in procuring international regulatory approvals on Delcath's Percutaneous Hepatic Perfusion (PHP) System; a combination oncology drug and device system.
John's expertise ranges from the lifting of FDA warning letters, gaining PMAs, INDs, 505(b)2, 510(k)s and IDE approvals as well as other international product approvals (FDA, CE and other non-EU countries).
John has over 25 years of extensive medical device experience in the areas of Quality, Clinical and Regulatory Affairs. From June 2008 to July 2010 (2 years 2 months) Greater New York City AreaVP QA & Regulatory Affairs @ -Sr. Consultant (Present)
-Vice President Regulatory and Clinical Affairs (2005-2006)
• Manages and directs all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for Class III Cardiovascular AF devices. Successful in gaining FDA IDE Clinical Approvals, Class II device approvals and European Union CE Mark for the company’s anchor products. Includes directing all clinical trial functions for Investigational Device Exemptions (IDE) and regulatory compliance, worldwide. From September 2005 to July 2008 (2 years 11 months) VP QA and Regulatory Affairs @ Selected Accomplishments:
Manages and directs all aspects of a Corporate QA Compliance & Regulatory Affairs Group, internationally for Class II combination products (drug and devices). From October 2006 to March 2008 (1 year 6 months) VP of QA, Clinical and Regulatory Affairs @ Vice President Regulatory/QA and Clinical Affairs
• Managed and directed all aspects of a Corporate Regulatory, Clinical Affairs and Quality System Groups for a medical electronic data capturing (EDC) company which provides medical e-CRF, Registry, Complaints Management, Data Management, Clinical Consulting, Regulatory Compliance, Clinical Project Management, Medical Image and medical modality data capture management through a sophisticated secure WEB Accessed System (Application Service Provider - ASP model). Ensured 21 CFR Part 11, c-GMP, c-GCP and EU Medical Device Directiveswere adhered to and applied to this new paradigm. Successfully procured first 510(k) WEB PACs device/service for the company as well as initiated 5 new features/services offer that is presently underdevelopment for a 2005 launch. From March 2004 to September 2005 (1 year 7 months) Greater Boston AreaVP Regulatory and Quality @ • Succeeded in bringing this medical device facility, under the pressure of a FDA Warning Letter, export hold and sixty-one I-483 GMP Observations, back to total compliance within 4 months of taking the position. The results were no FDA observations noted upon FDA’s re-inspection, GMP compliance, the lifting of export restrictions on the company and a subsequent successful PMA Class III and CE Mark approval on the company’s new product platform.
• Further FDA and Notified Body (CE Mark, Japan-Shonin, Canada) submittals totaled 12 approvals on new products (4 Class III and 8 510(k)s, 8 CE Mark, 2 Shonin), providing an increase in sales revenue of 30 - 45 %.
• Directed multi-site/country (6) IDE clinical trials on Cardiovascular devices (catheters, ICDs, etc).
• Assisted, selected and managed the quality of offshore manufacturing sites (Germany, Mexico) which helped reduce costs to the company by over 35%. From 2001 to March 2003 (2 years) Sr. Telemedicine Consultant @ • Consulted, investigated and identified sources of poor product quality for a large international telecom client (Italy, Spain) using 6 Sigma Principles. Presented findings to client’s executive management along with the steps which could be taken to realize a Total Quality Management process. The TQM process was accepted and implemented resulting in a potential quality cost savings of $ 34M.
• Succeeded in gaining ISO9000-3 certification for several divisions of AT&T. Co-authored Malcom Baldridge applications for the divisions. Collected audit data, compiled process information, and conducted non-threatening interviews with employees. Identified bottlenecks, and implemented comprehensive training as well as mock audits.
• Researched, adapted and implemented a comprehensive multi-divisional Quality Management training program (Quality Policy Function Deployment Process) to over 2,500 research and development engineers. Successfully scheduled, presented, and fielded questions concerning the new policies to groups of these individuals within a 2-month period.
• Directed all aspects of the corporate product presence at International medical device trade shows (Germany, Argentina, Italy). Worked with various in-house and outside personnel to design an attractive booth, understandable informational brochures, and
• proper merchandising of products. Our booth consistently remained one of the busiest at these events.
• Delivered a dynamic presentation as keynote speaker to a Telemedicine Asia-Pac Conference in Singapore and Japan. Researched, prepared, and served as expert
commentator on the history of Telemedicine to this international group of medical professionals.
• Started a New Jersey branch of a Florida medical device division (Class II devices) from the ground up. Hired and trained personnel, established operational policies, conducted clinical trials, regulatory submissions and purchased all needed equipment to perfor From 1989 to 2002 (13 years) Sr. Project Manager @ From 1997 to 2000 (3 years) Global RA/QA Director @ • Managed all aspects of a corporate regulatory, clinical affairs and quality program for a medical device manufacturer worldwide (7 sites) including hiring and firing, scheduling work and activities, budgeting, establishing policies and procedures, evaluating performance, and motivation of employees. Managed the quality compliance of offshore manufacturing sites. Successfully coordinated, authored, and submitted paperwork for 30 plus Class II & III new US Food and Drug medical device (510k & PMA) approvals.
Managed information, regulatory submittals and development of these new products at 7 manufacturing divisions worldwide.
• Reduced operational expenses 30% through a six-sigma process. Assembled a team of technicians, and equipment needed to facilitate safety testing of products and components in-house.
• Saved company $4.5M by providing an in-depth report on potential regulatory costs which was used to discount the purchase price of the acquisition. As part of this Product Acquisition Team we procured 4 new facilities through purchase of 2 companies and increased the product offer profile by 20 new product offerings.
• Managed groups of up of up to 45 exempt and non-exempt professionals with budget responsibilities up to $4M (yr. 1983) From January 1985 to June 1989 (4 years 6 months) Sr. Quality Engineer @ • Increased overall product quality levels for facility by 39%. Reviewed all workflow and associated processes, and established a new quality function which expanded the inspection team, testing department and field technicians. Generated SOPs for compliance to regulatory standards
• Established the Supplier Qualification Process with collaboration with the Purchasing team.
• Supervised Calibration Lab and assisted in establishing the CSA Testing Laboratory for the company. From 1981 to 1984 (3 years) Tampa/St. Petersburg, Florida Area
MBA, Contact Management @ Florida Institute of TechnologyBachelors in Engineering, Electrical, Mechanical @ Stevens Institute of Technology John Talarico is skilled in: International Management, Executive Management, Medical Devices, FDA, Regulatory Affairs, Quality Management, Quality System, ISO 13485, Clinical Research, Clinical Trials, Regulatory Submissions, Quality Assurance, Product Launch, Product Development, Healthcare
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