Senior Director, Global Regulatory & Clinical Strategy - Medical Devices #0405MM

Our client is seeking a Senior Director, Global Regulatory & Clinical Strategy to align regulatory strategy and clinical evidence planning across product development, submissions, and lifecycle management. This leader will play a critical role in ensuring evidence strategies are fit for intended use, product claims, geographic expansion, and evolving regulatory expectations.

This is a highly visible role for a senior leader who understands how clinical and regulatory strategy must work together to accelerate execution while protecting quality and compliance.

Key Responsibilities

• Lead integrated regulatory and clinical strategy for new products, indications, and lifecycle changes.
• Partner with Regulatory Affairs, Clinical, Quality, and Product teams to define evidence requirements and submission pathways.
• Support development of submission-ready clinical content and evidence summaries.
• Anticipate global regulatory questions and help drive response strategies.
• Guide risk-benefit narratives and evidence positioning for product claims and labeling.
• Influence portfolio decisions by clarifying regulatory and clinical tradeoffs.
• Strengthen cross-functional planning processes and governance across global markets.

Requirements

• Bachelor’s degree required; advanced degree preferred.
• Strong experience in medical devices, ideally in both clinical and regulatory-facing leadership roles.
• Knowledge of global submission strategy, clinical evidence frameworks, and regulated product development.
• Track record supporting complex submissions, design changes, or market expansion initiatives.
• Strong executive presence and ability to influence in matrixed environments.

Benefits

$220,000 - $285,000 base salary, plus bonus and long-term incentive opportunity.

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