St Andrews, Fife, United Kingdom
Compliance Director, Global R&D at Alere
Biotechnology
Education
Heriot-Watt University 1989 — 1993
BSc Hons, Optoelectronics and Laser Eng
Crawley College 2001 — 2002
City & Guilds, Programming in C++
Experience
Alere May 2013 - Present
UL September 1999 - May 2013
CSA April 1996 - September 1999
Skills
Program Management, Six Sigma, Regulatory Requirements, Clinical Trials, Testing, Regulatory Affairs, CE marking, Lifesciences, FMEA, Quality Management, ISO 17025, Product Development, Cross-functional Team..., Standards Compliance, V&V, Validation, Engineering, Electromagnetic..., ISO 14971, Medical Devices, New Business Development, ATEX, Quality System, Iso 9000, Change Control, Regulatory Submissions, Product Certification, Product Safety, FDA, R&D, RoHS, FCC, UL, Quality Assurance, Biotechnology, Risk Management, IEC, IEC 60601, GMP, EMC compliance, ISO 13485, Quality Control, DMAIC, Business Strategy, Design Control, CAPA, Root Cause Analysis, Quality Auditing, Calibration, ISO