Project Manager

is working on a large EU MDR remediation project and these roles will focus on packaging. Role would be to ensure compliance with ISO 11607. Their packaging is a mix of automation and manual processes, and will be all classes (I, II & III). May have to make some packaging design changes based on gaps found but that experience is a plus. Majority will not involve design.Will be investigation gaps that are found, conduct assessments, draft protocols and remediate the gaps. Build samples, protocol prep and report writing. Looking for 5+ years experience with Medical Device Packaging. Any EU MDR and design experience would both be a plus. Degree preferred but experience more important.