Position:
Director, Strategic Regulatory, MD&D at Johnson & Johnson
Work:
Johnson & Johnson
- Washington, DC since Nov 2011
-
Director, Strategic Regulatory, MD&D
Blackstone Medical/ Orthofix
Feb 2004 - Nov 2011
-
Sr Vice President RA/QA/CA
Spine Next
Feb 2003 - Feb 2004
-
Director RA/QA
Spinal Dynamics
Sep 1997 - Feb 2003
-
Vice President, Regulatory Affairs/Quality Assurance
Heart Technology
Jan 1995 - Sep 1997
-
Manager Regulatory Affairs
Food and Drug Administration
Jun 1990 - Dec 1994
-
Senior Scietific Reviewer
Education:
Drexel University 1980 - 1987
BS, MS, Materials Engineering
Skills:
Quality System, Regulatory Affairs, Design Control, Clinical Trials, Regulatory Submissions, V&V, PMA, Clinical Research, R&D, Orthopedic, ISO 13485, Spine, FDA, Program Management, CAPA, Strategy, Biomedical Engineering, Supplier Quality, Strategic Planning, Risk Management