Natalie Damrau
Sr Regulatory Affairs Manager @Euroimmun Us
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WORK HISTORY
Sr Regulatory Affairs Manager @Euroimmun Us
Mountain Lakes, NJ, US
EDUCATION
San Diego State University
Master of Science - MS, Regulatory Affairs
University of California, Davis
Bachelor of Science - BS, Biotechnology, Bioinformatics
ABOUT NATALIE DAMRAU
As a collaborative, strategic, and solutions-oriented Regulatory Affairs professional, I specialize in in-vitro diagnostics and software, bringing a wealth of holistic experience in facilitating lifecycle activities for both in-vitro diagnostic (IVD) and research use only (RUO) products. My career is built on a foundation of ensuring compliance and navigating complex regulatory landscapes to bring innovative healthcare solutions to market.Expertise- US Submissions: Extensive experience with Emergency Use Authorizations (EUA) and 510(k) premarket notifications, ensuring that products meet rigorous FDA standards- EU Submissions: Proficient in CE-Marking processes, guiding products through the stringent European regulatory requirements to achieve market readiness- Regulatory Intelligence: Skilled in gathering and analyzing regulatory information to inform strategic decisions and maintain compliance with evolving regulations- Project Management: Adept at leading and coordinating complex projects, balancing technical, scientific, and managerial responsibilities to achieve project milestones- Process Improvements: Continuously seeking and implementing process enhancements to streamline regulatory activities and improve overall efficiency.Throughout my career, I have demonstrated success in managing the scientific, technical, and people-oriented aspects of diverse and complex projects. I excel in leading and collaborating with cross-functional teams to ensure timely authorizations, clearances, and approvals for domestic and global markets, including the United States (US), Canada, Latin America (LATAM), Asia-Pacific (APAC), and Europe, the Middle East, and Africa (EMEA).My role often involves collaborating with various stakeholders, from regulatory bodies and internal teams to external partners, ensuring that all projects align with regulatory requirements and strategic goals. By staying abreast of industry trends and regulatory updates, I provide valuable insights and guidance that drive project success and contribute to the advancement of healthcare technologies.
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