A leading Medical Device company in Irvine, CA is seeking a Project Manager consultant to join their team ASAP for a project that will go for approximately 6 months . This consultant will need to be onsite every day . The PM will report to a leader within Corporate Regulatory Affairs.
This role will focus on the Quality Management System Regulation (QMSR 21 CFR 820) . We need a hands-on individual who is not only willing to lead but also to dive into the details. This consultant will assess the gaps between our current Quality Management System (QMS) and the new QMSR. In addition, the consultant will work closely with multiple stakeholders, including procedure and instruction owners, who will be affected by this change. Primary responsibility will be to ensure that the organization is fully compliant with the new rule by February 2, 2026.
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