Principal Regulatory Affairs

📋 Description

• Lead regulatory strategy across the surgical platform, including robotic and surgical systems
• Advise senior leaders on regulatory options for new products, significant design changes, and
• Lay out the regulatory risks, trade-offs, and recommended path for each option.
• Assess the regulatory health of assigned programs by identifying risks, gaps, dependencies, and
• Connect intended use, human factors, interoperability, and clinical workflow to classification
• Develop the submission strategy for premarket authorizations across pathways (510(k), De Novo, PMA

🎯 Requirements

• Minimum 15 years of related regulatory affairs experience with a bachelor's degree; or 12 years
• Bachelor's degree in engineering, life sciences, or a related technical discipline required; PhD
• Regulatory Affairs Certification (RAC) preferred.
• Experience with international standards development, standards interpretation, or the use of
• Deep expertise in regulatory strategy for complex medical device systems, including surgical
• Knowledge of the regulatory considerations for software, digital health, cybersecurity

🎁 Benefits

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