A highly dedicated Quality Assurance and Regulatory Affairs professional
with more than 20 years experience in the Medical Device, Laboratory and Pharmaceutical industries. Fully certified ISO Lead Auditor with considerable expertise in performing global audits.

• Proven track record in the implementation of Quality Management Systems to internationally recognised standards ISO (13485, 9001, 17025, 15189, 22870, 4971), FDA (21 CFR Part 820) and MDSAP.
• Proven track record in setting up ISO 15189 +ISO 22870 systems in compliance with Covid Testing
• Proven track record in achieving compliance to European, FDA and global regulatory requirements for both devices and pharmaceuticals, including combination products and software based systems.

Successfully led over 60 EU, FDA and ISO audits/inspections, including acting as host.