Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs
Agilent Technologies
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $163,753 - $286,950 per year
About the role
- 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.
Benefits
- Eligibility for bonus
- Stock options
- Health insurance
- 401(k) matching
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory project managementoperational excellenceprocess managementstrategic planningregulatory metricsKPI trackingcontinuous improvementstandardizationdata-driven decision makingdocumentation practices
Soft Skills
leadershipcommunicationorganizational skillsanalytical skillsbusiness acumencollaborationinfluencing skillsfacilitation skillspresentation skillsability to navigate ambiguity