John Maibauer

Background

About John Maibauer

An experienced leader in regulatory affairs with strong technical skills, work ethic, and regulatory knowledge. Given my computer sciences degree and experience at a copy center i was hired into regulatory affairs to work on regulatory operations. I was able to quickly learn regulatory concepts and transition from RA operations to RA strategy. I am able to leverage my technical background to better understand the products i work on and apply the relevant regulatory concepts. ACHIEVEMENTS As a Manager/Leader- Successfully developed team to manage SaaMD (recruited, hired, trained, and mentored staff)- Led, Coached, and Managed direct reports through multiple 510(k)s, IDE’s, CE Mark packages, & a Drug Master File - Led, Coached, and Managed direct report through development of next generation Dose Error Reduction System - RA lead on cybersecurity initiatives for division, helped implement policies and procedures Individual- Authored and received clearance for nine 510(k)s as submission owner - Authored and received 510(k) clearance for the company’s first SaaMD (Software as a Medical Device)- Authored and received approval for a Prior Approval NDA Supplement - Developed, led, and executed regulatory strategy for three brand new products, from concept to launch - Created and maintained ERC and STED file for multiple brand-new product families - Submitted applications and received 510(k) clearance and CE mark approval for 3 new indications on existing products (Plasma Procedure on Alyx, ECP for Amicus, PF24 for Amicus & Alyx)- Developed and implemented systems and processes for registration, project, and change management tracking as well as SPL authoring - Led RA strategy for Combination Product including authoring an RFD and receiving IDE approval for a Clinical Trial - Led many teleconferences with FDA, a face to face meeting with FDA, and a face to face meeting with an EU notified body