Clinical and Regulatory Affairs Manager

6 days ago

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SandboxAQ

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AI • Quantum Physics • Quantum Technology • Cryptography • Cybersecurity

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💰 $500M Venture Round on 2023-02

Description

• Ready to join the AQ era? • SandboxAQ is solving challenging problems with AI + Quantum for positive impact. • We partner with leaders to identify applications for quantum solutions. • Join a culture of diverse talent and technological impact. • Seeking a Clinical & Regulatory Affairs Manager for AQMed team. • Prepare for and initiate multi-site US pivotal study for CardiAQ™ device. • Develop regulatory strategies, submissions, and ensure compliance with regulations.

Requirements

• Bachelor's degree in biomedical engineering, life sciences, or related field; advanced degree preferred • Minimum of 10 years of industry experience in medical devices, serving in clinical and/or regulatory affairs, with significant leadership responsibility • 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 • Cool Under Pressure: You remain composed in challenging situations • Team Player & Builder: You foster collaboration across different engineering disciplines • Desire to Move Fast: You challenge the status quo • Detail-Oriented: You pay close attention to details • Passionate About Solving Unmet Medical Needs: Motivated to improve patient outcomes • Deeply Curious: Insatiable desire to learn • Thoughtful About Risk: Carefully assess risks

Benefits

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