Agilent Technologies seeks a Regulatory Master for Regulatory Planning and Operations within its Diagnostics Regulatory Affairs (DRA) organization. This role is a leadership position responsible for blending operational leadership, process ownership, and strategic planning to support a global IVD regulatory portfolio.
What You'll Do
- 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 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 the DRA leadership team, 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.
What We're Looking For
- Bachelor’s degree in a scientific discipline.
- 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.
Nice to Have
- Advanced degree.
Team & Environment
You will be a key member of the DRA leadership team and the Global Regulatory Affairs (GRA) extended leadership team, serving as a key partner to the head of the department.
Benefits & Compensation
- Compensation range of $163,753.00 - $286,950.00/yr plus eligibility for bonus, stock and benefits.
Work Mode
This is a hybrid position.
Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels.
