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Accredited by Engineers Australia, I am a highly skilled Chemical Engineer with a Master's degree and over 5 years of experience in the medical device... View More
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Certifications
- Project Management Diploma - IHBC
- Advanced Excel Course - Unapec
- Operations Management – Quality GB
Accomplished regulatory affairs/ quality Assurance professional with extensive expertise in EU PRRC, EUAR, UKRP, and NIRP. Proven track record in ISO ... View More
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Certifications
- 10/01/13, QMS Auditor / Lead Auditor for ISO 13485, 9001 – QCS International UK 01/01/23, SaMD (software as a Medical Device) Certification – GMP training. 01/01/23, TUV SUD (UK) Lead IVD Academic Trainer
Detail-oriented Quality Engineer with 4+ years of experience in the medical device industry, focusing on quality assurance, supplier collaboration, re... View More
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Biomedical engineer and Quality/Risk SME with 6+ years in medical devices. Experienced in FDA 510(k), ISO 13485/14971, and CAPA-driven risk management... View More
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Certifications
- Risk Management (ISO 14971 Certified, FMEA, CAPA integration)
- Design Control & Regulatory Submissions (FDA 510(k), PMA support)
- Computer Software Validation (21 CFR Part 11)
With a proven track record at Biosystems Diagnostics, I've excelled in enhancing quality compliance and operational efficiency, leveraging skills in I... View More
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To work in an organization that provides the opportunity to utilize my professional expertise effectively and creatively to meet the organizational go... View More
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Accomplished Regulatory Affairs Officer with over 25 years of experience in developing streamlined processes and executing regulatory initiatives acro... View More
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Certifications
- ASQ Certified Quality Engineer, 1999-01-01, not renewed
- Six Sigma Black Belt, 2001-01-01
- Red X Journeyman, 2003-01-01
Strategic Healthcare R&D and Innovation leader with deep expertise in global healthcare product development, regulated medical device innovation, port... View More
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Skilled Pharmacist with strong background in regulatory compliance, pharmacological knowledge and patient care. Detail-oriented professional goes extr... View More
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Certifications
- ISO 13485 Internal auditor
- Bachelor Of Pharmacy
Experienced Regulatory Affairs Specialist and Project Manager with a strong background in CE Marking Compliance, Medical Device Certification, and EU-... View More
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Certifications
- 48 Hours, Business English, University of Aveiro
- 104 Hours, Postgraduate Master’s in Quality Management – ISO 9001 Internal Auditor, Quality Management System, SGS Porto, Portugal
- 32 Hours, ISO 9001 Internal Auditor, SGS Porto, Portugal