Benjamin Klein
Manager Regulatory Submissions at Philip Morris International
Based in Morges, Switzerland
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Seniority
Manager
Department
Other
Location
Morges
Industry
Manufacturing
Company size
65K
Contact information
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b•••••••@pmi.com
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Background
About Benjamin Klein
17+ years’ experience in Quality Assurance & Regulatory Affairs Management within the Medical Device industry (small and medium-sized companies) and FMCG corporation, operating in highly regulated environment - Proven track record as executive and operational leader in creating, maintaining and leading of full Quality Management System for 3 startups and successfully obtaining market approval for medical devices from class I to in both EU and US markets - Biomedical engineer by training, with extensive experience in leading projects through all stages, including design control, verification & validation, design transfer, process validation. Additionally experienced in pre- and post-clinical research • High skilled in ISO 13485, MDR 2017/745 & CE Mark approval and FDA 21 CRF part 820 & 510k clearance
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