Clinical and Regulatory Affairs Manager

Summary

Join SandboxAQ's AQMed team as a Clinical & Regulatory Affairs Manager to lead the preparation and initiation of a multi-site US pivotal study for CardiAQ™, navigate regulatory landscapes, and develop strategies for global market success.

Requirements

• Bachelor's degree in biomedical engineering, life sciences, or a related field; an advanced degree is preferred
• Minimum of 10 years of industry experience in medical devices
• Experience preparing regulatory submissions for the FDA, including successful approvals of 510(k) and/or de-novo
• Experience launching and managing multi-center pivotal studies; international site management experience is a plus

Responsibilities

• Lead US pivotal study launch
• Manage and optimize ongoing US feasibility studies
• Write clinical study protocols and clinical study reports
• Manage clinical research activities, including site selection & qualification
• Expand and cultivate our relationships with international clinical partners
• Formulate, communicate, and implement regulatory strategies for the CardiAQ™ device
• Lead US FDA regulatory submissions and negotiation
• Collaborate with R&D, Quality, and Manufacturing to ensure product development aligns with industry requirements
• Review and approve labeling, advertising, and promotional materials for compliance purposes

Benefits

• Competitive salaries
• Stock options depending on employment type
• Generous learning opportunities
• Medical/dental/vision insurance
• Family planning/fertility benefits
• PTO (summer and winter breaks)
• Financial wellness resources
• 401(k) plans