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Bruna Duarte
Quality Specialist Lead @Aspen Pharma Eme
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WORK HISTORY
Quality Specialist Lead @Aspen Pharma Eme
IE
EDUCATION
Instituto Racine
Master's degree, Regulatory Affairs and Medical Product Registration at ANVISA
Sorocaba Technological College (FATEC)
Bachelor's degree, Biomedical Technology/Technician
Technological University of the Shannon
Postgraduate Degree, Process Validation and Regulatory Affairs - Pharmaceutical
SKILLS
ABOUT BRUNA DUARTE
Bilingual (Portuguese and English) b••••••••@gmail.com +35••••••••40I am a bilingual professional (Portuguese and English) holding a Biomedical Technology Technician Degree, Postgraduate in Regulatory Affairs and overall 7 years of experience in regulatory affairs, medical device technician and quality for the medical devices industry. Proven experience in ensuring compliance with industry regulations, collecting scientific data, handling license submissions, updating legislation knowledge, and supporting teams developing new products. Career HIghlights- Examined and compiled the Labeling, Advertising and Promotional materials with Regulatory Compliance- Reviewed and approved quality system documents to determine compliance with regulatory regulations and standards- Designated as a Lead Quality Auditor for internal audits system- Assisted Regulatory and Quality departments in maintaining QMS- Developed SOPs, policies, and process documentation- Knowledge in “RDC 16/2013 - Good manufacturing practices of medical devices and In vitro Diagnostic devices” and ISO 13485, development of indicators, improvement in quality procedures and instructions.Achievements-Successfully managed to relocate all medical products of Kindly from one city to another within Brazilian borders according to municipal law and sanitary surveillance alone and without previous experience, received all correct Certificate of Conformity before the deadline.LION™ - LinkedIn Open Networker
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