Interim regulatory support for a global manufacturer

When a large medical device manufacturer unexpectedly lost their principal specialist for clinical evaluation, they needed immediate interim support to maintain regulatory compliance.

I stepped in to provide hands-on assistance with Clinical Evaluation and PMS activities, working closely with cross-functional teams to ensure business continuity.

During this period, the company successfully passed two Notified Body audits without major findings. Beyond interim support, I also mentored the newly hired specialist and delivered on-site training for the team — ensuring a smooth transition and lasting regulatory competence within the organization.