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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
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RAPS Focus
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Networking Opportunity
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Ticketed Event
Student Focus
Student Focus

Sanja Matern, PhD, RAC Devices (she/her/hers)

Director Regulatory Information Management
Fresenius Medical Care Deutschland GmbH
Bad Homburg, Hessen, Germany

Experienced in Regulatory Affairs and team leadership ensuring the regulatory compliant product development and successful world-wide registration of innovative medical devices and in-vitro diagnostics. With years of experience in regulatory affairs and quality management (including RAC Device Certification), and a PhD in Biochemistry and Molecular Biology, I have a strong background and expertise in the field of healthcare and life sciences.
I am passionate about delivering high-quality products and services that improve human health and well-being. I have a proven record of world-wide regulatory submissions including US FDA and Notified Body and several Quality Award wining projects. I also drive the regulatory strategy development for the submissions, work within industry associations groups, and lead the RA community and SOP implementation. I enjoy working with cross-functional teams, solving problems, and facing new challenges. My goal is to make global submissions a success story. I led the team of Regulatory Affairs Professionals at Siemens Healthineers, and now focusing on Regulatory Information Management, regulatory strategy and processes within Fresenius Medical Care.

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