Team management, responsible for marketing company Quality Management System management (ISO 9001). Internal audits, supplier audits. Complaints handling, Field actions, change controls, CAPA.

Lead project for Quality Management System implementation (ISO 13485) for marketing company including warehouse. Internal audits, complaints handling, change controls, CAPA. Responsible for supervision of registration processes for medical devices in Central Europe, Southeast Europe and Baltic states.

Responsible for Regulatory team – MENA, Balkan states, Baltic states, Africa, Pakistan, India. Registration processes and direct communication with Authorities and MOH. Creating, Maintaining and revision of Medical Devices Technical Files (STED) per EU Medical Device Directive 93/42/EEC. Project Management of EU projects (Brexit preparation, MDR). Responsible for labelling compliance. Virtual Manufacturers portfolio managements. CAPA processes, Internal audits.

Regulatory Affairs Medical Devices international team management (Germany, Czech Republic). Communication with Notified Bodies, certification process. Project Management in area of Medical Device Regulatory projects in EMEA region (re-certification within acquisitions). Regulatory Affairs documentation gap analysis. Creating, Maintaining and revision of Medical Devices Technical Files (STED) per EU Medical Device Directive 93/42/EEC. Creating, Maintaining and revision of Medical Devices Master… Show more Regulatory Affairs Medical Devices international team management (Germany, Czech Republic). Communication with Notified Bodies, certification process. Project Management in area of Medical Device Regulatory projects in EMEA region (re-certification within acquisitions). Regulatory Affairs documentation gap analysis. Creating, Maintaining and revision of Medical Devices Technical Files (STED) per EU Medical Device Directive 93/42/EEC. Creating, Maintaining and revision of Medical Devices Master texts and Artworks. Support for regulatory affairs local offices within international registrations and notifications of medical devices. Cooperation with marketing, QA, logistic, business development within EMEA region. Corporate communication. Show less

Project Management in area of Medical Device Regulatory projects in EMEA region (re-certification within acquisitions). Regulatory Affairs documentation gap analysis. Creating, maintaining and revision of Medical Devices Technical Files (STED) per EU Medical Device Directive 93/42/EEC. Creating, Maintaining and revision of Medical Devices Master texts and Artworks. Support for regulatory affairs local offices within international registrations and notifications of medical devices.

Project management: Plastic extrusion real-time line monitoring and data collection. Plastic re-granulation process and its improvement and evaluation of effectiveness. Creation of project documentation. Internal project audits. R&D of plastic casing for food industry.

Implementation of new products in the area of medical devices from the phase of development until full production phase. Creating of documents under the quality system – SOPs, WI, forms. Staff training. Performing a validations of manufacturing process, packaging and sanitation. Responsible for the quality of work within the manufacturing instructions. Manages team working on new product implementation.