Sweden
Regulatory Affairs at EuroDiagnostica
Medical Devices
Education
The Royal Institute of Technology (Kungliga Tekniska Högskolan) 1986 — 1991
MSc, material science
Experience
EuroDiagnostica August 2012 - Present
BONESUPPORT September 2010 - August 2012
BONESUPPORT AB May 2007 - September 2010
Medtronic June 2005 - April 2007
Biomet 2004 - 2004
Medtronic Functional Diagnostics January 1998 - January 2001
Siemens Medical Solutions 1995 - 1997
The Royal Institute of Technology 1992 - 1994
Skills
Commercialization, Pharmaceutical Industry, CAPA, Regulatory Affairs, 21 CFR, Pharmaceutics, Medical Devices, Design Control, Orthopedics, ISO 14971, Quality Assurance, PMA, Market Access, 21 CFR Part 11, Clinical Research, R&D, Life Sciences, Biomedical Engineering, V&V, Validation, Regulatory Strategy, IVD, ISO 13485, 510 K, Medical Device Directive, Biotechnology, Regulatory Requirements, GCP, FDA, Quality Management, Risk Management, Orthopedic, Strategy, Product Development, Lifesciences, CE marking, Clinical Trials, GMP, FDA GMP, Quality System, Regulatory Submissions, Biomaterials