Regulatory Affairs Specialist

• Mar 2022 - Present

Medical Device Consultant

• Jan 2022 - Mar 2022

Quality & HSE Specialist / Internal Auditor

• May 2016 - Jan 2022

- Conducting internal quality system audit. - Reviewing of procedures , operative instructions and working processes. - Developing new electronic document management system. - Keeping under control and manage training courses outcomed from Management Review. - Developing and enforce the health & safety system. - Conducting internal quality system audit. - Reviewing of procedures , operative instructions and working processes. - Developing new electronic document management system. - Keeping under control and manage training courses outcomed from Management Review. - Developing and enforce the health & safety system.

Quality & Safety Assistance / Internal Auditor

• Jan 2013 - May 2016

- Management and coordination of activities necessary to conform and abide by the ISO 9001:2008.13485:2012 and OHSAS 18001:2007 standards.- Collaboration with the quality manager during audits, management review, defining target area and plan relative activities.- Initial planning and application of the quality system in North American Tethis office according to CFR 21 part 820. (on site)- Setting up the US warehouse, organizing the distribution net and logistics of product to keep the traceability of the products under control (on site)- Conducting internal quality system audit.- Collaborating with the health and safety team. Show less

Admin & Import/Export specialist

• Feb 2009 - Jan 2013

- Invoicing- Organising travel arrangements for international meetings and product demonstrations- Arranging logistics for national and international shipments, import and export documentation- Management of inventory and fiscal documentation