SARA L. THEISPost Office Box 111506 Campbell, California 95011

(612) 889-8284 ssss925@hotmail.com

SR. REGULATORY AFFAIRS SPECIALIST

10 years in Quality-Driven ISO Environments including over 5 years direct Regulatory Affairs experience in Medical Device, IVDs and Instrumentation

EXPERIENCE SUMMARY Creator of regulatory IVD diagnostic dossiers for International Markets (Classes 2 & 3) for

cancer tumor markers and blood analytes Developer of Technical Files for the EU Medical Device Directive (MDD) and CE Mark Versed in regulatory pathway determinations for Medical Device Instruments and Accessories Assessor of regulatory impact for product changes to process, procedure and labels Highly organized team player with a proven record of consistently meeting deadlines and

project requirements

PROFESSIONAL EXPERIENCE

AMERICAN MEDICAL SYSTEMS, INC. San Jose, CaliforniaRegulatory Affairs Labeling Specialist (Contractor) 2011 - Present Evaluator of labeling changes for 5 Laser Systems (Class 2) and 11 fiber optic and laser fibers

(Class 2) Publish internal Labeling Gap Analysis report and Best Labeling Practices for Manuals and

Instructions for Use Maintained compliance to US FDA, ISO13485, IEC 60601, IEC 60825, ISO 14971, ANSI Z136,

EN 29001, FDA, GMP, ICH, 21 CFR standards, Federal, State and Local Regulations

ALIGN TECHNOLOGY, INC. / CADENT, INC. San Jose, CaliforniaRegulatory Affairs Analyst 2010 – 2011 Integral employee in launching new configuration for dental medical device convenience packs

to Invisalign product line Recommended strategic regulatory guidance to product development teams for Ancillary kits Assessed regulatory impact for product changes to process, procedure and labels for Invisalign

clear braces Registered Align products in China and Russia. Authored 1 new license and 6 amendments

for Health Canada. Implemented domestic product updates with US FDA Filed establishment licenses for new Align offices with Health Canada and US FDA

MERIDIAN BIOSCIENCE, INC. Cincinnati, Ohio Global Regulatory Affairs Specialist 2007 – 2009

Prepared and submitted over 100 regulatory submissions for diagnostic products to market for Canada, Japan, Singapore, Malaysia, China, South America and other regions

Authored 45 EU technical files for Class 2 and 3 IVD pathogen and virus tests Coordinated pre-IDE with design team and supported product launch to relevant governmental

organizations, 3rd party registrars and distributors Created site master files and facility related submissions Classified Meridian Bioscience portfolio of products comprehensively in foreign countries Initiated international communications and face to face meetings with international clients Confirmed USDA and BIS Export Regulations (EAR) per 15 CFR for all shipments MSDS reviewer for the portfolio of 100+ Meridian products

Resume for Sara L. Theis Page 2 of 2

PROFESSIONAL EXPERIENCE (Continued)

MERIDIAN BIOSCIENCE, INC. Cincinnati, Ohio

Managed quality system documentation to ISO 13485, ISO 14971, FDA, GMP, ICH, ISO labeling and 21 CFR standards

BECKMAN COULTER Chaska, Minnesota Global Regulatory Affairs Coordinator (Contractor) 2003 – 2004

Prepared and submitted 46 regulatory submissions for new IVD tumor marker products to market for Latin America, China, Singapore, Australia, New Zealand, Poland, Czech Republic, Taiwan, Turkey, India and Indonesia

Authored NCCLS, CLIA, and CLSI Product Inserts Authored standard operating procedures and work instructions for use by RA and other teams.

Products consisted of PMA IVDs and some 510(k) IVDs Interacted with and transferred critical information to International regulatory partners ABBOTT LABORATORIES Ross Products Division, Casa Grande, ArizonaQuality Assurance Specialist, Microbiology Lab 1997 – 2000

Quarantined spoiled product valued at $ 2 million dollars averting a field recall of infant formula Investigated root causes of CAPAs and implemented changes to UV water filtration system

serving as an improvement to all production lines Maintained compliance with USDA, US FDA, ISO, Federal, State and Local regulations

ABBOTT LABORATORIES Diagnostics Division, Abbott Park, IllinoisTechnical Product Development Specialist, Toxicology Business Team 1995 – 1997

Supervised six scientists as project team leader Launched Abbott’s upgraded in-vitro diagnostic FPIA assays to a global market increasing the

product portfolio to $100 million. Validated the AxSYM instrument prior to market launch Reengineered training requirements increasing relevance to job description and ultimately

saving 15% of the training budget As a board member of the plant safety initiative reduced site accidents by 12% Updated Package Insert content. Verified labels for box, bag and vial in-vitro diagnostic kits Operated in a DEA, US FDA, ISO, Federal, State and Local regulated environment

Other Management Roles 2001 – 2003, 2005 – 2007

EDUCATIONMaster of Business Administration May 2001Arizona State University, Tempe, Arizona

Bachelor of Science in Bacteriology May 1995University of Wisconsin-Madison, Madison, Wisconsin

LANGUAGES AND COMPUTER PROFICIENCY French at an advanced level. Basic Spanish reading and recognition of technical phrases.

Recognition of European, Latin American and Asian languages MS Office Suite, Office Live, Project, PeopleSoft, TrackWise, AS400, VISIO, Quicken,

QuickBooks, Documentum, ARENA, AGILE, EDMS, Master Control and Lotus Suite