Regulatory Master, Regulatory Planning and Operations – Diagnostics Regulatory A

Job Description

We are seeking an experienced Regulatory Affairs leader to oversee regulatory planning and operations for Diagnostics Regulatory Affairs (DRA). This role is ideal for someone highly organized and strategically minded who can drive departmental efficiency and ensure operational excellence. S/he will be a key member of the DRA leadership team as well as the Global Regulatory Affairs (GRA) extended leadership team and serve as a key partner to the head of the department.

The role blends operational leadership, process ownership, cross-functional coordination, and strategic planning to support a dynamic global IVD regulatory portfolio.

Key Responsibilities

• 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.

Qualifications

• 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.

Personal Characteristics

• 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.

Additional Details

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