Romer De Los Santos

I’m a professional with over 20 years of experience developing software in the medical device industry. I have a proven track record for driving process improvements, introducing design controls to teams entering the medical device space, and for bringing focus to highly complex projects. Regulatory Experience: HIPPA, IEC62304, ISO13485, ISO14971, ISO8601, 21 CFR Part 11, 21 CFR 820, IVDR, cGMP, GDP, QSR Languages and Skills: CSPO, CSM, Jama, JIRA, Confluence, Agile PLM, SAP PLM, Scrum, Requisite Pro, Visual Studio, MS Office, MS Project, Visio, Balsamiq, Oscilloscope, DICOM, C#, WPF, XMAL