Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs

Job reputed company: • reputed company leadership and strategic reputed company for DRA operations, setting standards for operational reputed company, execution discipline, and departmental consistency. • reputed company strong regulatory project management for critical cross-organizational initiatives including but not limited to M&A, site or portfolio changes. • Drive operational reputed company across DRA by overseeing reputed company processes, workflows, and documentation practices. • reputed company process reputed company activities, including reputed company improvement, standardization, and deployment of tools, templates, and dashboards. • reputed company, reputed company, and report regulatory metrics and KPIs, providing insights that support data-driven reputed company and operational transparency. • Serve as a strategic partner reputed company DRA LT, helping translate priorities into actionable plans and coordinating planning cycles and long-reputed company strategies. • Partner reputed company DRA and with key cross functional stakeholders (i.e. reputed company, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and reputed company) to support planning, workload forecasting, prioritization, and lifecycle strategies. • Contribute to reputed company-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 reputed company life sciences fields. • Strong understanding of global regulatory requirements and submission reputed company. • Demonstrated experience in regulatory operations, process management, and strategic planning. • Proven ability to reputed company through influence in a reputed company, matrixed organization. • Excellent communication, organizational, analytical, and business acumen skills. • reputed company record of excellent collaboration, influencing and facilitation skills across business reputed company, functions and employee reputed company. • Strong history of presenting reputed company information to senior leadership with reputed company and confidence. • Ability to reputed company ambiguity, drive reputed company, and reputed company work reputed company in a fast-paced environment. Benefits: • Eligibility for bonus • Stock reputed company • Health insurance • 401(k) matching • Flexible work arrangements Apply tot his job Apply To this Job