Konstanz Area, Germany
Senior Consultant Regulatory/Quality/Legal Affairs
Medical Devices
Education
The University of Edingburgh / Edinburgh Law School 2014 — 2015
Medical Law and Ethics LLM, Medical Law, LLM
University of Applied Sciences Furtwangen 1999 — 2003
Bachelor of Business Administration (BBA)
AAMI
FDA Design Controls regulations
AAMI
FDA CAPA regulations
AAMI
Product Risk Management regulations
AAMI
FDA QSReg part 820
Experience
Self-employed September 2001 - Present
Johnson & Johnson April 2013 - April 2014
Lead consultant January 2008 - January 2014
Roche September 2012 - April 2013
Lead Consultant January 2012 - February 2013
Lead Consultant January 2010 - January 2012
Skills
Form FDA 483, Warning..., Project Management, Laparoscopic Surgery, Preparation and..., Quality Assurance, ISO 13485:2003 audit..., Surgery, Qualification,..., Training on GMP, Market Planning, Clinical Evaluation..., Registration, licensing..., Assessment of the..., Regulatory Affairs -..., Implementation of the..., Consultation process..., FDA, European authorized..., Medical Devices, FDA (21 CFR 820 QSR)..., Creation of target..., Urology, ISO 13485 consultants..., Administration, U.S. FDA 510 (k)..., Preparation of..., Implementation of GMP /..., Audits of clinical..., Compliance with quality..., CE marking, Medicine, Endoscopy, Evaluation, assessment,..., Compilation of..., Advice on Canadian..., Surgical Instruments, Geographical targeting..., Planning, compilation..., Company registration..., Representative and..., ISO 13485, Profiling the ideal..., Medical Device License..., Spine, CE marking for Medical..., Determination the best..., Admission and..., Management support of...