Agilent Technologies

Premier Laboratory Partner for a Better World

Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs

ComplianceComplianceFull TimeRemoteTeam 10,001+Since 1999H1B SponsorCompany SiteLinkedIn

Location

California

Posted

23 days ago

Salary

$163.8K - $287.0K / year

Bachelor Degree12 yrs expEnglish

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.

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

  • Eligibility for bonus
  • Stock options
  • Health insurance
  • 401(k) matching
  • Flexible work arrangements

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