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Premier Laboratory Partner for a Better World
Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs
Location
California
Posted
119 days ago
Salary
$163.8K - $287.0K / year
Seniority
Lead
Job Description
Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs
Agilent Technologies
• 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.
Job 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.
Benefits
- Bonus
- Stock options
- Health insurance
- Paid time off
- Work remotely
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