Senior Director, Global Regulatory & Clinical Strategy – Medical Devices

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🕒 March 19

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Keller Executive Search International

WebsiteLinkedInAll Job Openings

11 - 50 employees

🎯 Recruiter

👥 HR Tech

Recruitment • HR Tech • Professional Services

Keller Executive Search International is a global executive search firm specializing in helping organizations find exceptional leadership talent. With a network spanning numerous cities around the world, they provide recruitment services, transition planning, employee coaching, and leadership development. Committed to diversity and sustainability, Keller offers high-quality, tailored executive search solutions across various industries. Their services include recruitment process outsourcing, military transitions, and succession planning, with a focus on finding the right leaders to drive business success globally. Keller is recognized for its robust assessment practices and a comprehensive suite of HR advisory services.

📋 Description

• 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. • Equal Employment Opportunity and Non-Discrimination Policy. • Commitment to Diversity. • Reasonable Accommodations. • Compliance with Laws. • Workplace Harassment. • E-Verify Participation. • Privacy and Pay Equity.