Product Owner

Experience creating medical data management, data transfer and data storage systems including relevant standards

Specialist in business/system analysis and process design, leveraging up-to-date knowledge of applicable tools and techniques and imparting their knowledge to the wider Product Owner team

Ensure User Stories and product requirements meet the market needs and align to the Product/Technical Enabler Roadmap

Creating medical devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals

Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant

Skills Required
product requirements , User Stories, Gcp, 21 Cfr Part 11, business system analysis , Gmp, Process Design