Clinical & Regulatory Affairs Manager at SandboxAQ in United States Full Time

Responsibilities:

• Lead US pivotal study launch with clinical operations.
• Manage ongoing US feasibility studies with clinical sites.
• Write clinical study protocols and reports for publications.
• Manage clinical research activities and site selection.
• Formulate and implement regulatory strategies for CardiAQ™.
• Lead FDA regulatory submissions and negotiations.
• Collaborate with teams to ensure product development alignment.
• Review and approve labeling and promotional materials.
• Submit regulatory filings to international bodies.

Requirements:

• Bachelor’s degree in biomedical engineering or life sciences.
• Minimum of 10 years in medical device clinical/regulatory roles.
• Experience with FDA regulatory submissions (510(k), de-novo).
• Experience in managing multi-center pivotal studies.
• Cool under pressure and able to manage technical challenges.
• Strong team player with a focus on collaboration.
• Fast-paced, detail-oriented, and risk-aware.
• Passionate about solving unmet medical needs.
• In-depth knowledge of FDA regulations and global standards.

Benefits:

• Competitive salary ($183k-257k per year).
• Annual discretionary bonuses and equity.
• Medical, dental, and vision insurance.
• Family planning and fertility benefits.
• Generous PTO, including summer and winter breaks.
• 401(k) plans and financial wellness resources.
• Learning and development opportunities.