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Florus Lowag

Global Director of Regulatory Affairs and Compliance at Sequana Medical

Florus Lowag has a diverse work experience in regulatory affairs and compliance. Florus worked at Sequana Medical NV as the Global Director of Regulatory Affairs and Compliance, where they were responsible for ensuring regulatory compliance and managing regulatory affairs. Prior to this, they were the Global Director of Quality Management and Regulatory Affairs at the same company.

Before joining Sequana Medical NV, Florus Lowag worked at Medela as the Global Manager Regulatory Intelligence. In this role, they provided consultancy and support to project teams during product development and lifecycle. Florus also conducted reviews of regulatory information, coordinated cross-functional activities, and maintained relationships with external industry associations. Florus also held the position of Global Regulatory Affairs Manager & Special RA Projects at Medela, where they assisted project teams with risk management, licensing, and compliance to international regulations.

Florus Lowag's earlier experience includes working at Karl Storz Endoskope as a Systems Engineer, where they developed endoscopic devices and ensured compliance with regulations and standards. Florus was responsible for risk management, system requirements, technical documentation, and external product testing.

Florus also gained experience through their roles as a Masterthesis and Practice Project at KARL STORZ GmbH & Co KG, and a Bachelorthesis at Phacon GmbH.

Overall, Florus Lowag has a strong background in regulatory affairs, compliance, and quality management, with experience in various industries including medical devices and healthcare.

Florus Lowag obtained a Bachelor of Engineering (B.Eng.) degree in Elektrotechnik und Informationstechnik, with a specialization in Kommunikationstechnik, from HTWK Leipzig. This education took place from 2008 to 2011. Florus then pursued a Master of Science (M.Sc.) degree in the same field of study, with a focus on Kommunikationstechnik und Biosignalverarbeitung, from HTWK Leipzig as well. This degree was earned from 2011 to 2013.

In 2017, Florus Lowag obtained a Certificate in Manager Regulatory Affairs Medical Devices International from Technische Hochschule Ulm.

In addition to their degrees, Florus Lowag has a certification as a CQI and IRCA Certified Quality Management Systems Lead Auditor, incorporating ISO 13485:2016 and MDSAP requirements. Florus obtained this certification from NSF HEALTH SCIENCES in October 2017.

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Timeline

  • Global Director of Regulatory Affairs and Compliance

    July, 2020 - present

  • Global Director Quality Management and Regulatory Affairs

    July, 2019