|Desired Industry: Biotech
|Desired Job Location: Red Bank, New Jersey
||Date Posted: 2/21/2010
|Type of Position: Full-Time Permanent
||U.S. Work Authorization: Yes
|Job Level: Executive (President, VP, CEO)
||Willing to Travel: Yes, 25-50%
|Highest Degree Attained: MBA
||Willing to Relocate: Undecided
Creative, enthusiastic, resourceful professional executive with over 20 years of successful international regulatory approvals for Class I, II, III, medical products and quality standards compliance (cGxPs, ICH, ISO) domestically and internationally. Proven track record and expertise in international operations, developing projects and policies, which result in meeting business objectives and the launch of new products. Expertise in international strategic planning of product regulatory pathways (EU, Shonin, SFDA, FDA), increase quality of an old product, and/or adjust work processes towards increased operational efficiency. Proven skills in global management, analysis, organization, troubleshooting, regulatory compliance, motivation, speaking in public, and building strong beneficial partnerships and relationships with customers, marketing, manufacturing and the product development team.
DELCATH SYSTEMS, INC 2008- Present
- Sr. Vice President Regulatory and Quality Systems
Manages and directs all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for Class III Combination device - oncology drugs company. Successful in gaining FDA and SFDA(China) IND / IDE Clinical Approvals. Includes directing all clinical trial functions for Investigational Device Exemptions (IDE), Investigation New Drug (IND), 505(b)2 NDA, PMA, SFDA, Shonin and CE Mark submissions. Responsible for regulatory compliance, worldwide.
PRORHYTHM, INC 2005- 2008
- Independent Sr. Consultant (Present)
- Vice President Regulatory and Clinical Affairs (2005-2008)
Managed and directed all aspects of a Corporate QA, Regulatory and Clinical Affairs Group for International Class II & III Cardiovascular AF devices. Successful in gaining FDA IDE Clinical Approvals and European Union CE Mark for the companys anchor products. Includes directing all international clinical trial functions (EU, Japan, USA) for Investigational Device Exemptions (IDE), CE, Shonin, PMA and 510(k) submissions. Was responsible for regulatory compliance, worldwide.
KIKA MEDICAL, INC 2004- 2005
Vice President Regulatory/QA and Clinical Affairs
Managed and directed all aspects of a Corporate Regulatory, Clinical Affairs and Quality System Groups for this French medical electronic data capturing (EDC) company which provided global 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 Directives were adhered to and applied to this new paradigm. Market focus was Medical Device and Drug Combinations (Class II and III); including, CE, Shonin, SFDA, PMA submittals and IDE studies for Cardiology, Orthopedic and invitro devices. Successfully procured first 510(k) WEB - PACs device/ASP service for the company as well as initiated 5 new features/services offer.
EP MEDSYSTEMS, INC 2002- 2004
Vice President QA/Regulatory Affairs and Company Export Officer
Succeeded in bringing this medical device facility, under the pressure of a FDA Warning Letter and sixty-one I-483 GMP Observations, back to total compliance within 4 months
of taking the opportunity. The results were no FDA observations noted upon FDAs re-inspection, GMP compliance, the lifting of export restrictions on the company and a
subsequent PMA Class III and CE Mark approval on a 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
IDE clinical trials on Cardiovascular Invitro 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%.
AT&T/ BELL LABS /AVAYA, INC. 1990 2002
- Sr. Telemedicine Marketing Consultant
- Healthcare Marketing Director
- Medical Device/Applications Subject Matter Expert
- Quality Manager (NOS International)
- QA/Regulatory Affairs Manager
Selected Accomplishments with ATT/Bell Labs/Avaya:
Consulted, investigated and identified sources of poor product quality for a large international telecom client (Italy, Spain). Presented findings to clients 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 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 perform R&D as well as quality, regulatory and marketing activities for the parent corporation.
PPG BIOMEDICAL SYSTEMS (FORMALLY HONEYWELL MEDICAL) 1986 1990
Divisional Regulatory Affairs Director
Managed all aspects of a corporate regulatory, clinical affairs and quality program for a medical device manufacturer worldwide (7 sites Germany, France, Netherlands, Mexico) 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 (Germany, Netherlands, Mexico). Successfully coordinated, authored, and submitted paperwork for 30 plus Class II & III new US Food and Drug medical device (510k & PMA) and CE Mark approvals. Managed information, regulatory submittals and development of these new products at the 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)
JOHNSON & JOHNSON (CRITIKON, INC.) 1981 1985
QA Engineering Supervisor
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. Supervised Calibration Lab and assisted in founding the CSA Testing Laboratory for the company
PHARMACO-KINESIS INC, LOS ANGELOS, CA 2009-Present
INREX TEST, INC, NYC, NY 2009-Present
WORLD MEDICAL DEVICE ORGANIZATION, SWITZERLAND 2009-Present
EXCELSIOR MEDICAL, INC, NEPTUNE, NJ 2006- 2008
MBA, Florida Institute of Technology
BE, Stevens Institute of Technology
ASQ, RAPS, AAMI
Available upon request.
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