I am a regulatory expert with a solid background in biomedical engineering and proven track record in product, process development and validation of drug device combination products and medical devices. I am currently located in Basel, Switzerland, where I work among others for Novartis. I have experience with global submissions, agency interactions and authoring dossiers (e.g. Notified Body submissions) and possess a comprehensive understanding of Quality Management Systems, Design Controls, Clinical Evaluations, Risk Management and Human Factors Engineering based on the following regulations, guidances and standards:• Medical Device Regulation 2017/745.• FDA QSR.• ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes.• ISO 14971 - Medical devices - Application of risk management to medical devices.• ISO 10993 - Biological Evaluation.• Food and Drug Administration (FDA) - Design Control Guidance for Medical Devices Manufacturers.• IEC 62366-1 - Human Factors and Usability EngineeringI am passionate about Getting Things Done (GTD) methodologies, applying and teaching them with excellent results.