Regulatory & Compliance - GxP; ICH; CE IVDR; ISO17025;ISO 13485; FDA 21 CFR part11
I’m a Project Manager with 15+ years in the BioMedTech and life science sectors, specializing in New Product Introductions and global market expansion. With an M.Eng. in Biotechnology and an MBA in BioMedTech, I combine scientific expertise with strategic execution to lead cross-functional innovation from concept to launch.
Over the past 7 years, I’ve delivered complex, high-impact projects at Illumina, Axolabs, and Precision for Medicine, managing full project lifecycles with a hands-on, structured approach—ensuring scope clarity, risk control, and cross-functional alignment across technical, regulatory, and commercial teams.
Global role as Program Manager in New Market Expansion with focus on market entry of IVD medical device in the emerging geographies
Biomarker-guided clinical trials and immune monitoring solutions, global central lab and bioanalytical services
A platform-based instrument manufacture offering a wide range of protein tools for research and product quality control in biopharmaceutical research industry.
Lab-automation and service provider - ultra-low volume liquid handling and microarray technologies
Development of a diagnostic lateral flow assay for rapid detection of
procalcitonin (PCT)
Regulatory & Compliance - GxP; ICH; CE IVDR; ISO17025;ISO 13485; FDA 21 CFR part11
Project Management Tools - MS Projects / Asana / Confluence / SmartSheets
Business CRM & Quality - SFDC, SAP, Teamcenter