This position has the responsibility for developing and implementing global medical device regulatory strategy. S/he is also responsible for addressing and resolving regulatory issues in preclinical, manufacturing, clinical and commercial development programs. The position interacts with all levels in the organization, participating in discussions with management and providing strategic regulatory guidance. What will you do? Provide Strategic Regulatory Guidance to Management and Inter-disciplinary Project Teams Serve as lead regulatory representative to provide effective regulatory leadership to project team and clinical development teams for clinical stage products. Strong knowledge of FDA, EU, TGA, cGMP and ISO 134