Regulatory Master – Regulatory Planning and Operations, Diagnostics Regulatory Affairs

📋 Description

• Provide leadership and strategic guidance for DRA operations, establishing benchmarks for operational excellence, execution discipline, and departmental uniformity.

• Deliver robust regulatory project management for key cross-organizational initiatives, including but not limited to M&A, site or portfolio modifications.

• Enhance operational excellence across DRA by managing core processes, workflows, and documentation standards.

• Oversee process-related activities, including continuous improvement, standardization, and the implementation of tools, templates, and dashboards.

• Develop, monitor, and report on regulatory metrics and KPIs, supplying insights that facilitate data-driven decisions and operational transparency.

• Act as a strategic collaborator within the DRA Leadership Team, assisting in converting priorities into actionable plans and coordinating planning cycles and long-term strategies.

• Collaborate within DRA and with key cross-functional stakeholders (such as Quality, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and Commercial) to aid in planning, workload forecasting, prioritization, and lifecycle strategies.

• Contribute to enterprise-level initiatives that necessitate DRA operational leadership or strategic input.

⛳️ Requirements

• Bachelor’s degree in a scientific field; advanced degree is preferred.

• Over 12 years of experience in regulatory affairs within IVDs, medical devices, or related life sciences sectors.

• In-depth knowledge of global regulatory requirements and submission pathways.

• Proven experience in regulatory operations, process management, and strategic planning.

• Demonstrated capability to lead through influence within a complex, matrixed organization.

• Exceptional communication, organizational, analytical, and business acumen skills.

• Strong history of effective collaboration, influencing, and facilitation skills across various business groups, functions, and employee levels.

• Proven ability to present intricate information to senior leadership with clarity and confidence.

• Capability to navigate ambiguity, drive clarity, and advance work in a fast-paced environment.

🏝️ Benefits

• Bonus

• Stock options

• Health insurance

• Paid time off

• Work remotely