Tamara Astrup
Regulatory Affairs Specialist @Heraeus Medevio
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WORK HISTORY
Regulatory Affairs Specialist @Heraeus Medevio
Dresden, DE
EDUCATION
Volga State University of Technology
Bachelor's degree, Biomedical/Medical Engineering
ABOUT TAMARA ASTRUP
I work as a Regulatory Affairs Specialist in medical devices with over 5 years of experience supporting EU and international market access. My expertise includes regulatory submissions, technical documentation, CE marking, vigilance activities, and QMS compliance in line with ISO 13485 and ISO 14971. I collaborate with cross-functional global teams, notified bodies, and authorities to align regulatory strategies with EU MDR and FDA 21 CFR 820 requirements.
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