• Preparing, maintaining, reviewing, and updating regulatory and technical documentation to support FDA submissions, including Pre-Submissions (Q-Subs) and preparation, coordination, and participation in FDA meetings • Acting as a primary regulatory interface for communication with the FDA, including drafting, coordinating, and submitting responses to FDA inquiries within defined timelines • Preparing and supporting activities required for FDA clearance, approval, and ongoing compliance, including 510(k), DeNovo, and PMA submissions, as applicable • Supporting the development, implementation, and continuous optimization of the regulatory strategy for the US/FDA market • Working closely with the Regulatory Affairs team in Vienna to ensure alignment between US and global regulatory activities • Coordinating regulatory activities with our US-based regulatory consultant and internal cross-functional stakeholders • Ensuring a thorough understanding and correct interpretation of FDA regulations applicable to in vitro diagnostic medical devices, with a strong focus on multiplex tests • Supporting internal and external audits, FDA inspections, and regulatory reviews, including preparation of documentation, follow-up actions, and responses • Contributing to post-market surveillance, change management, and life-cycle activities, as well as the preparation and maintenance of SOPs, work instructions, and templates, where relevant