James joined Advena as the Medical Device Quality Management Consultant/Manager. He has 25 years broad experience in Quality Assurance and Regulatory Affairs, which he gained working in Medical Device manufacturing (Class I to Class III) and whilst working for a leading Notified Body. He is well positioned to support Advena clients establish and maintain compliant Quality Management Systems. Also an IRCA Certified ISO13485 Lead Auditor, James can identify compliance risks and areas for improvement that support the client business goals, and conformity to relevant requirements.
Purdy Ellul
Business Administration - Team Leader (Malta)
Over 6 years experienced in Business Administration, Customer Service, Account Management and sales.
Bijayata Upadhyay
Medical Device Regulatory Consultant
Bijayata has >10 years experience as a medical device regulatory consultant and has specialised in the preparation of technical files…
Polina Sobolevskaia
Business Administrator (Malta)
Polina, originally from Russia, joins the Advena team as a Business Administrator after completing her MBA in Business Administration in…