I was responsible for the regulatory affairs activities and strategies.Assignments include: • Creating, coordinating and reviewing regulatory submissions for international projects, including FDA change notices and EU consultation dossiers (CTD) for drug-device combination products.• Leading the regulatory team in providing regulatory support to customers and functions within the company. • Responsible and coordinator for the standards management process procedure. • Trademark coordinator – working with trademark counsels and authorities worldwide to expand trademark registrations and overcome refusal decisions.

I was a project manager for development and improvement projects in R&D, manufacturing and quality control. Assignments included:• Product development, including design verification and validation studies.• Process and test method development. • Risk management activities, including assessment of product and process risks. • Responsible for the design control process procedure.• Responsible for the computer system validation procedure. • Competitive intelligence (CI) coordinator – Responsible for CI activities, including gathering and analysis of intelligence on competitors, customers, suppliers and focus technologies.

I was responsible for developing of and maintaining business relationships with distributors and end users of in-vitro diagnostic devices in Europe. Assignments included organizing and executing marketing activities, customer and distributor meetings and training events.

I was responsible for marketing and sales activities of medical coatings and technologies to new customers. I was also responsible for the business relationship with existing customers.

Assignments included:• Development and validation of manufacturing processes, equipment, and test methods. • Project manager for customer projects, including all phases from concept and feasibility to validation of manufacturing and final product. • Scientific and technical support to manufacturing and quality control.• CAPA support.• Statistical design and analysis, including design of experiments, general statistical analysis and statistical process control.