Steve Jwanouskos's Email Addresses & Phone Numbers

📖 Summary

Beekeeper @ 4308 Silva Avenue From March 2012 to March 2013 (1 year 1 month) Robertsville, CAAvid listener to the New Wood radio show (7 a.m. to 10:00 a.m.) Thursdays @ KKUP From 1992 to 2010 (18 years) Sr. Director, Regulatory and Quality Compliance @ Boston Scientific Corporation From 1994 to 2001 (7 years) Mgr., Clinical and Regulatory @ Cardiometrics, Inc. (acquired by EndoSonics, Inc., 1996) From 1992 to 1994 (2 years) Clinical Research @ Scheider U.S.A. (acquired by Boston Scientific, 1995) From 1990 to 1992 (2 years) Technical and Medical @Writer @ GV Medical, Inc. From 1988 to 1990 (2 years) Jwanouskos Regulatory Consulting @ Principal Consultant From March 2017 to February 2018 (1 year) San Jose, CAJwanouskos Regulatory Consulting @ Principal Consultant Available for long-term, long distance engagements on novel medical device solutions to unmet clinical needs. Roseville, MNRegulatory Affairs, Project Manager (Advertising & Promotion) @ Abbott/Saint Jude Medical Global, post-commercialization Advertising and Promotion reviews for regulatory compliance, on all diagnostic and therapeutic electrophysiology products within the Saint Jude Medical business unit of Abbott. All media (social networks, printed materials, journal ads, billboards, holograms) were subject to reveiw. Additionally, contibuted to the on-time and on-budget completion of a complete rebranding, from Saint Jude Medical's webpages to become Abbott's, post-acquisition. From February 2018 to November 2018 (10 months) Saint Paul, MNAssociate Director Regulatory Affairs @ Abbott Medical Optics Abbott Medical Optics acquired OptiMedica Corporation in August, 2012. Contributed to the foundation 510(k) and two subsequent 510(k)s, and globalization to many foreign markets including Asia-Pacific, Europe and Latin America. Advanced femtosecond laser guided by optical coherent tomography for cataract surgery. Retained by Abbott after the acquisition with a two-year salary bonus. From August 2012 to January 2017 (4 years 6 months) Sunnyvale, CAAssociate Director, Regulatory Affairs @ OptiMedica Corporation Femtosecond laser-assisted cataract surgery. From October 2011 to August 2014 (2 years 11 months) Abbott Medical Optics (Sunnyvale, CA) formerly OptiMedica Corporation)Vice President, Regulatory, Clinical and Quality @ Allux Medical Technologies, Inc. (Menlo Park, CA) Novel programmed electronic medical system designed to deliver ultraviolet phototherapy for allergic rhinitis. Secured 4 non-significant risk (NSR) determinations for clinical studies and executed a randomized, controlled, double-blind clinical trial in the U.S. For this trial, we enrolled 192 patients at 2 sites, treated all in 3 weeks, followed all in 1 month and reported an interim analysis at 9 weeks. Hired a Quality Engineer and a Clinical Research Manager. Established a quality system for risk management and product release, and coordinated data entry, statistical analyses, and clinical monitoring through three Clinical Research Organizations. From February 2005 to June 2006 (1 year 5 months) Vice President, Clinical and Regulatory Affairs @ Calypso Medical (acquired by Varian, 2011) Responsible for U.S. regulatory and clinical planning and execution. Established the initial IDE with 5 sites and 40 patients. Calypso has developed a programmable electronic medical system for locating permanently implanted magnetic “markers”. The miniature transponders can be located by the system (“GPS for the body”) to thereby target non-resectable tumors continuously during external beam radiation therapy. Premarket notification was cleared in July 2006, following my recommendations on the regulatory strategy and indication for use. From May 2003 to November 2005 (2 years 7 months) Vice President, Regulatory, Clinical and Quality @ TransVascular, Inc. (acquired by Medtronic, 2004) Company was acquired by Medtronic. While at TransVascular, I directed world-wide regulatory and clinical programs. I was also responsible for the ISO 9001/46001 Quality System and GMP compliance. Novel technology platform combining IVUS and transvenous or trans-arterial techniques for percutaneous bypass, intramyocardial injection, and other peripheral applications. Obtained 510(k) approval for the centerpiece technology without clinical data (7 months via third party review). Introduced the same technology to Europe via CE Marking. With the entire TVI team, achieved important milestones in multiple first-use-in-human clinical applications: (1) percutaneous coronary bypass in Germany (after system re-design), (2) an intramyocardial injection system, (3) percutaneous femoral-femoral bypass, and (4) percutaneous aortic fenestration. Hired two directors (Clinical and Quality), managed one European Clinical Director and additionally promoted from within the departments. From February 2001 to May 2003 (2 years 4 months) Director of Regulatory Affairs @ Cutera, Inc. Responsible for global regulatory submissions for the company's complete line of aesthetic lasers. From January 2017 to March 2017 (3 months) Brisbaine, CA