• Provide input to regulatory and clinical strategies of all CZM products for the US market to ensure adequate and most efficient 510ks, PMAs, and IDEs • Participate in strategy and management meetings, as needed to provide guidance and Agency perspective • Demonstrated expertise in the design and implementation of complex clinical strategies to support global regulatory and market needs. • Expertise in the design and execution of clinical studies which optimize the use of clinical data for global product approvals • Coach / train CZM organizations on US requirements (e.g. product design / design controls, clinical requirements, marketing material review et al.) • Review product claims and plans for substantiation of those, and decides upon adequacy of claim substantiation • Prepare and participate in meetings with US FDA • Conclude on adequacy of promotional and educational materials for appropriate regulatory content in case of unclear aspects. • Support Product Complaint investigations, as required. • Support BIMO audits, as needed • Driving resolutions of questions from FDA, pre- and post-market