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