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Expert ID: 732325 Minnesota, USA

Expert in Medical Devices, Business Development, Regulatory Affairs, Project Management

Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…

Expert ID: 733372 New York, USA

Expert in Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing

Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…

Expert ID: 733346 Connecticut, USA

Expert in Medical Device Regulatory Affairs: CE (Canada) and FDA

Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…

Expert ID: 731924 Illinois, USA

Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant

BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…

Expert ID: 731324 Sweden

Expert in Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs

ExpertS. Expert has over 33 years of experience in safety evaluation- Toxicology & Pathology – histopathology slides evaluation, Regulatory, drug discovery & development research, having worked in Switzerland, UK, Sweden and India. He has experience both in the pharmaceutical Industry…

Expert ID: 730387 United Kingdom

Expert in Software – Quality Assurance, Regulatory Affairs and Licensing

Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

Expert ID: 729387 Germany

Expert in Drug Regulatory Affairs (European Union)

Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany,…

Expert ID: 729312 India

Expert in Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market

Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…

Expert ID: 726001 Netherlands

Expert in Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market

She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…

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