Principal Regulatory Affairs Strategist

📋 Description

• Develop and lead early regulatory strategy for the surgical platform and its product families —
• Shape product direction early in the product life cycle and advise on the regulatory consequences
• Develop regulatory strategies for both US and OUS markets.
• Translate regulatory strategies into detailed, executable plans.
• Advise senior leaders and cross-functional teams on regulatory risks, trade-offs, and decision
• Define the clinical evidence strategy needed to support regulatory authorization for novel or

🎯 Requirements

• Minimum 15 years of related regulatory affairs experience with a bachelor's degree; or 12 years
• Bachelor’s degree in engineering, life sciences, clinical science, or a related technical
• Experience working with Clinical Affairs, Clinical Operations, investigators, or clinical experts
• Experience defining and executing clinical evidence programs, including early feasibility and
• Experience with regulatory considerations for software, digital health, cybersecurity, data-enabled
• Experience supporting diligence, partnership, acquisition readiness, or investment decision-making

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
• Target compensation ranges are listed.