Regulatory Affairs & Quality Assurance Specialist | Medical D evices | ISO 13485 | FDA | ECTD | Scientific Documentation

With a strong scientific foundation and practical regulatory experience, I help organizations strengthen compliance, improve documentation quality, and meet regulatory expectations efficiently.

• Medical devices
• pölymer drug delivery and nanotechnology
• Regulatory Affairs
• Chemistry and microbiology
• DIN EN ISO 13485
• ICH guidelines
• ISO14971 and 21CFr
• Medizinischer Kodierer
• Pharmacovigilance
• Quality associate

Regulatory Affairs and Quality Assurance professional with 9+ years of experience supporting medical device compliance, quality management systems (QMS), regulatory submissions, and scientific documentation. I hold a Ph.D. in Chemistry and bring strong expertise in FDA 21 CFR 820, ISO 13485, ISO 14971, eCTD implementation, CAPA, technical documentation, pharmacovigilance, and scientific writing.

My background combines regulatory affairs, quality assurance, and research and development experience, with particular expertise in polymer drug delivery, nanotechnology, chemistry, microbiology, and healthcare compliance. I have a proven track record of preparing, reviewing, and maintaining regulatory and technical documents in line with international standards and regulatory requirements.