Strategic management function to ensure global labeling compliance based on local regulations for Medical Devices and / or In-Vitro Diagnostic Medical Devices. Ensure compliance with international standards referring to labeling, includig electronic labeling (e-labeling).Management of ILS (International Labeling Systems) label creation teams in US and Germany and international translation teams established centrally or on a remote basis.Keep up-to-date and implement state-of-the-art technologies of the business, resulting in reduced errors and reduced cycle times; Drive cost reduction initiatives.Development of personnel and training on staff level, define and implement plans for process improvements. Support Third Party Suppliers with the creation and translation of files.

Supervision of regulatory activities required to maintain regulatory compliance of In-Vitro Diagnostic Devices (IVD) in Europe, Middle East, Africa (EMEA) & Pakistan markets.Manage team of Regulatory Managers located in EMEA and Pakistan focusing on product registration, post market surveillance activities and trade association participation Coordinate launch activities of new products,Support local technical and clinical studies in Russia as part of the registration activities.Ensure compliance with the new regulations in Africa and Middle East, Russia and CIS countries.Coordinating and supporting Audits from various international authorities including audits for tender purposes.Interpretation of the new requirements of the IVD regulationActive member of the German IVD trade association VDGH as well as the MedTech Europe and Mecomed, support commenting of new regulations in Russia, South Africa and other countries within the area. Supporting creation of In Vitro Diagnostic analyzer and (standalone) software guidance documents.

Supervision of regulatory activities required to maintain regulatory compliance of In-Vitro Diagnostic Devices (IVD) in Europe, Middle East, Africa (EMEA) & Pakistan markets.Support local affiliates within EMEA & Pakistan to maintain compliance with internal procedures as well as ISO standards for certified affiliates.Implement strategies and processes for effective supplier and Distributor control.Support affiliates during external as well as internal audits, and ensure implementation of an effective CAPA system

Manage R&D product development projectsCommercialization of high throughput Laboratory AutomationValidation and launch of Third Party Manufactured Clinical Chemistry and Immunoassay productsSupport scientific publications

Production, testing and troubleshooting of Hepatitis Immunoassays according to GMP- and GLP guidelinesProduct Transfers9 direct reports

Head Product Specialist for Hepatitis B and C immunoassay products