***** *****, LLC

Save time and money by funding the right assistance to overcome quality and regulatory issues. I provide expertise and staffing to resolve problems, to develop capabilities and to get products to international markets quickly.

Asia Pacific Regulatory and Quality Assurance Manger
3M
May 2006 – July 2008 (2 years 3 months)

Asia-Pacific Regional Manager for a leading provider of medical and oral care products, and drug delivery and health information systems. Focused on products related to infection prevention and skin and wound care such as single-use medical tapes, dressings, surgical drapes, skin antisepsis preps, masks, electrodes and stethoscopes. Additional support provided for the medical device component market, including Medical, Surgical, Ostomy, Electrodes, Optical, Retail and Diagnostics.
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VP Medical Services
BSI Asia
July 2003 – May 2006 (2 years 11 months)

Interface with individual country managers in terms of financial performance to budget for medical services. Conducted numerous marketing / training campaigns resulting in new business of GBP400k in first 18 months of establishing the business and growth to over GBP800k in subsequent year.
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VP / Director
TÜV America
2001 – 2002 (1 year)

Managed Profit and Loss Statement for $8.5 million business, resulting in an increase of 4% in total sales and 2.5% in operating results from prior year (through November 2002). Increased employee utilization (billable hours) to 75% from 60%. Established fixed-fee pricing structure for clients based on manufacturing bill-of-material concepts.
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VP RAQA
Mentor Urology (acquired by Coloplast)
1999 – 2001 (2 years)

Led Quality Management for two operating divisions of Mentor (Surgical Urology Products – US$53 million and Clinical and Consumer Healthcare – US$46 million) designing, manufacturing and distributing products for the treatment of Prostrate Cancer, Bladder Cancer, Erectile Dysfunction, and Female Pelvic Floor Disorders and for the management of Urinary Incontinence in five locations throughout Minneapolis and Anoka, MN. Division Management Representative. Reported directly to Corporate Vice President Quality and Regulatory Compliance in Santa Barbara, CA.
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Director Quality Operations
Ohmeda (acquired by Becton Dickenson)
1995 – 1999 (4 years)

Led the Quality Operations Division of a US$65 million manufacturer of thermodilution catheters, central venous multi-lumen catheters, associated introducer kits and blood pressure monitoring intravascular administration sets. Successfully cleared 3 Warning Letters issued by US FDA within 18 months on the job. Reported directly to Vice President/General Manager for Worldwide Critical Care Systems in USA.
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Quality Engineer
EP Technologies (acquired by Boston Scientific)
1993 – 1995 (2 years)
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Quality Assurance Manager
Baxter Healthcare
1986 – 1993 (7 years)

Accademia Qualitas
Certificate Canadian Medical Devices Conformity Assessment System
2003 – 2003
Activities and Societies: Successfully passed an examination covering the knowledge of Canadian Medical Devices Regulations, CMDCAS and ISO *****
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Stat-A-Matrix
Certificate ISO 9001 Lead Auditor w/ Emphasis on ISO *****
2003 – 2003
Activities and Societies: Registered Auditor/Lead Auditor Training for the Medical Device Industry
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Hamline University School of Law
2002 – 2002
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Texas Tech University
MS Mathematics
1984 – 1986
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Louisiana Tech University
BS Mathematics
1980 – 1984
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Statistics, TQM, Sterilization, and Biocompatibility Seminars
HACCP/Rule 11/AAMI Standards Training and Seminars

RAPS; Linkedin

PUBLICATIONS / SPEAKING ENGAGEMENTS

Speaker: Medtec China, Shanghai, August 2010
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Regulation of Medical Products in the European Union, ACCSQ Medical Products Working Group Pre-workshops, Makati City, Metro Manila, The Philippines, January 2008
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Risk Management for Medical Devices: Perspectives of both the manufacturer and the regulator, Taipei, Taiwan, June 2007
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Field Corrective Actions: A Comparison of US FDA and EU Regulatory Requirements, Joint Commission on Trade and Commerce, Beijing, China, June 2006
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Asian Regulatory Updates- Japan and Greater China, ***** Stuttgart, Mar 2006
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Observer – 3rd Meeting of the ASEAN Consultative Committee on Standards and Quality (ACCSQ) - Medical Devices & Equipment Product Working Group, Feb 2006
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Five Common ISO *****:2003 Problems, China Medical Device Manufacturer, Dec. 2005
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Medical Device Regulations in Asia-Pacific Markets, Management Forum Ltd., London, UK, Nov. 2005
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Understanding Japan PAL, Minneapolis, MN and Los Angeles, CA, Nov. 2005
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Utilizing Harmonized Standards in Product Development and Quality Management Systems, Taipei, Taiwan, Sep. 2005
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An Overview of Product Registration for Hong Kong, Taiwan and Japan, Medical Alley, MN, Nov 2004
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Roadmap for Biotechnology: From Innovation to Commercialization, Hong Kong Biomedical Conference, Oct 2004
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An Overview of IVD Directives, China IVD Manufacturer’s Association, Shanghai, PRC, Jul 2004
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BSI China presents the 510(k) Symposium, Learning the ***** Process for Submissions, Changzhou, PRC, Jul 2004
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Obligations to ***** Technical Documentation and STEDs, AHWP Technical Committee 3, Taiwan, Apr 2004
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A Comparison of Medical Device Regulations; Canada and Australia, Malaysia MOH, Nov 2003
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RAPS - Introduction to Regulatory Affairs and US FDA Warning Letters, Washington, DC, June 2003
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Design Changes and Quality System Regulations, DIA Medical Device Conference, San Francisco, Feb 2003
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Endotoxins, Pyrogen and LAL Testing of Medical Devices, Sep 2002 Notified Body Training Session
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Update on ISO *****:2003 – Results of Berlin WG Meeting, TÜV News, Fall 2002
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Medical Device Directive – The Design Dossier, TÜV News, Fall 2002
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Canadian Medical Device Conformity Assessment System (CMDCAS) Update, TÜV News, Spring 2002
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ISO *****:2003 Update, TÜV News, Fall 2001
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Quality Management and Regulatory Compliance Meeting on Global Harmonization Among the Combined Businesses of Infusion Therapy Systems, Anesthesia Systems and Critical Care Systems, B-D Infusion World, 1998
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A Particulate Matter: Monitoring Multi-Lumen Catheters per FDA Expectations, B-D Infusion World, 1998
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Global Harmonization of Regulations and Challenges to Becton Dickinson, B-D New-World Company, 1998