During an extensive, varied career in the medical devices and biotech industries, I have gained considerable expertise in the ***** , Compliance, and Manufacturing functions for invasive medical devices, biotech products, IVD’s, and combination products. In addition, I have successful experience with quickly and efficiently establishing GMP compliant ***** systems and obtaining CE marking for medical devices, including preparation, presentation, and defense of technical files and design dossiers. I have hosted numerous successful 3rd party audits, including FDA, FDB, and Notified Body audits preparatory to receiving a California manufacturing license, PMA approvals and granting of the CE mark. When establishing ***** systems and compliance programs, I drive to achieve simple, clean operations that enhance company effectiveness and meet regulatory requirements.