Senior Director, Global Regulatory & Clinical Strategy – Medical Devices
Keller Executive Search International
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $220,000 - $285,000 per year
Job Level
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyclinical strategysubmission pathwaysclinical content developmentevidence summariesrisk-benefit analysisportfolio managementevidence positioningsubmission supportproduct development
Soft Skills
influenceleadershipcross-functional collaborationexecutive presencestrategic thinkingcommunicationgovernanceproblem-solvingnegotiationdecision-making