Michael J. Andrews, Ph.D.

4 Krauser Road Downingtown, PA 19335 (610) 458-7998 PROFILE A skilled regulatory affairs professional specializing in medical devices and bi ologics with significant experience in regulatory affairs and clinical trial man agement, including Class III implantables and PMA devices. Six years with the F DA's Office of Device Evaluation. * * * * * * Quality system developer International regulatory affairs Excellent analytical skills Strategic thinker Good communication skills Skilled in staff development

PROFESSIONAL EXPERIENCE Aesculap Implant Systems, LLC; Center Valley, Pennsylvania Director, Regulatory Affairs and Quality Assurance; 2006 - Present; Accountable for Regulatory Affairs, QA, QC, and Clinical Studies * Set company direction as a member of the Executive management Team * Established a world class quality system and product development process that resulted in four clean audits in a one year period * Successfully conducted first IDE clinical trial in company's history, complet ing enrollment ahead of schedule * Seven direct reports and overall responsibility for 36 employees * Budget responsibility of $9.5M Siemens Medical Solutions, Inc.; Malvern, Pennsylvania Senior Manager, Regulatory Affairs; 2004 - 2006; Accountable for all domestic re gulatory affairs * Guided preparation of FDA submissions and the review of all advertising and pr omotional materials * Clinical trial design and evaluation * Audited for QSR compliance * Member of NEMA Technical and Regulatory Committee Impulse Dynamics; Mt. Laurel, New Jersey Director, Regulatory Affairs; 2003 - 2004 * Responsible for FDA and international submissions * Provided of regulatory oversight to the manufacturing operation * Developed and implemented strategy to achieve marketing approval for the compa ny's products * Developed clinical protocols that supported the regulatory and product develop ment strategies * Review and approval of all labeling, advertising, and promotional materials * Development and implementation of the regulatory process for post market surve illance Animas Corporation; Frazer, Pennsylvania Director, Regulatory Affairs; 2001 - 2003; Worldwide regulatory affairs responsi bility * Achieved certification to the Medical Device Directive and ISO 13485 and obta ined CE Marking for the company's devices * Accountable for Medical Device Reporting, Vigilance Reporting, and Canadian Pr

oblem Reporting and the Corrective and Preventive Action Program * Achieved compliance with the JCAHO and HIPAA requirements * Management Representative for the Quality system * Representative for FDA QSR inspections and Notified Body assessments Ampersand Medical Corporation; Chicago, Illinois Vice President, Regulatory Affairs, Quality Assurance, and Clinical Affairs; 200 0 - 2001; Worldwide regulatory affairs and clinical trial responsibility * Liaison with the FDA and international regulatory agencies for approval of com pany's medical devices * Managed clinical investigations of company's medical devices * Established and managed quality system Telectronics Pacing Systems; Englewood, Colorado (1993-2000) Vice President, Regulatory Affairs; Accufix Research Institute;1997-2000; Worldw ide regulatory affairs responsibility * Managed information systems activity for the company * Member of the HIMA Postmarket and Quality System Subcommittee Director, Regulatory Affairs; 1993-1997; Worldwide regulatory responsibility for all bradycardia, tachycardia, and cardiomyoplasty devices, including compliance and patient registration * Directed the preparation of all submissions, including design dossiers for CE Marking * Member of the AdvaMed Pacemaker Task Force Storz Instrument Company; St. Louis, Missouri Director, Clinical and Regulatory Affairs; 1991-1993; Accountable for worldwide regulatory affairs * Planned and executed clinical trials for the company's medical devices * Regulatory Affairs representative on the quality improvement task force * Directed the preparation of 510(k)s, PMAs, IDEs, and international filings Cell Technology, Inc.; Boulder, Colorado Vice President, Clinical and Regulatory Affairs; 1988-1991; Accountable for worl dwide regulatory affairs and clinical trials * Wrote a successful IND application * Achieved orphan product designation for one of the company's biologic products * Successfully managed multicenter clinical trials of the company's biologic res ponse modifiers * Developed company's first quality system * Set the strategic direction of the company as a member of the executive manage ment team CooperVision CILCO; Bellevue, Washington (1983-1988) Director of Regulatory Affairs; 1984-1988 Regulatory Affairs Manager; 1983-1984; worldwide regulatory and clinical respons ibility for Class III implantable products * Established the company's regulatory affairs and clinical departments * Designed and managed all clinical investigations * Achieved premarket approval for the company's devices * Company's liaison with the FDA and a member of the HIMA Ophthalmic Interest Co mmittee Food and Drug Administration; Silver Spring, Maryland (1977-1983) Investigational Device Exemption Program Coordinator; 1981-1983 Biophysicist, Program Management Staff; 1980-1981 Reviewer; Hematology Branch, Division of Clinical Laboratory Devices; 1977-1980 * Wrote FDA's initial device classification regulations for hematology devices * Developed FDA policy for implementation of the Medical Device Amendments * Developed FDA's system to assure that IDE applications were reviewed and proce ssed within the statutory deadline

FACULTY APPOINTMENTS University of Colorado Health Sciences Center; Denver, Colorado Clinical Assistant Professor, Department of Preventative Medicine and Biometrics ; 1988-1991 Alma College; Alma, Michigan Visiting Assistant Professor of Physics; 1977 EDUCATIONAL BACKGROUND Ph.D., Biophysics; Georgetown University; 1976 M.S., Biophysics; Georgetown University; 1975 B.S., Physics; Michigan State University, 1970 Certified Instructor; Quality Education System; Philip Crosby Associates, Inc.; 1992 HONORS Phi Beta Kappa