Highlander Consultants
FL, USA
09th February, 2026 Job Summary: We are seeking a Mechanical Engineer with a strong regulatory affairs background to serve as a key technical and regulatory bridge between Engineering and Regulatory functions. This role is mechanically centered, with mechanical engineering as the primary discipline and core specialty, while also fulfilling critical regulatory affairs support responsibilities throughout the product lifecycle. The Mechanical Engineer - Regulatory Liaison will perform mechanical design and development activities for medical device products while ensuring regulatory requirements are appropriately integrated into engineering outputs. Reporting to the Director of Engineering, this position supports design controls, Design History Files (DHF), risk management, regulatory documentation, and compliance activities in accordance with FDA and applicable international standards. This role serves as a primary liaison between Engineering and Regulatory Affairs,...
