Regulatory Master, Regulatory Planning and Operations – Diagnostics Regulatory Affairs

Job Description: • Provide leadership and strategic oversight for DRA operations, setting standards for operational excellence, execution discipline, and departmental consistency. • Provide strong regulatory project management for critical cross-organizational initiatives including but not limited to M&A, site or portfolio changes. • Drive operational excellence across DRA by overseeing core processes, workflows, and documentation practices. • Lead process related activities, including continuous improvement, standardization, and deployment of tools, templates, and dashboards. • Develop, track, and report regulatory metrics and KPIs, providing insights that support data-driven decisions and operational transparency. • Serve as a strategic partner within DRA LT, helping translate priorities into actionable plans and coordinating planning cycles and long-range strategies. • Partner within DRA and with key cross functional stakeholders (i.e. Quality, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and Commercial) to support planning, workload forecasting, prioritization, and lifecycle strategies. • Contribute to enterprise-level initiatives requiring DRA operational leadership or strategic input. Requirements: • Bachelor’s degree in a scientific discipline; advanced degree preferred. • 12+ years of regulatory affairs experience in IVDs, medical devices, or related life sciences fields. • Strong understanding of global regulatory requirements and submission pathways. • Demonstrated experience in regulatory operations, process management, and strategic planning. • Proven ability to lead through influence in a complex, matrixed organization. • Excellent communication, organizational, analytical, and business acumen skills. • Track record of excellent collaboration, influencing and facilitation skills across business groups, functions and employee levels. • Strong history of presenting complex information to senior leadership with clarity and confidence. • Ability to navigate ambiguity, drive clarity, and move work forward in a fast-paced environment. • Transformational leader who brings intensity & excitement every day with a desire to excel and inspire others. • Resourceful creative thinker willing to explore unique, out-of-the-box solutions. • Persistent in the face of resistance and adaptable to rapid change. • Ability to weave complex concepts into a clear compelling message. • Ability to identify and focus on key priorities. Benefits: • bonus • stock • benefits