Manager, Regulatory Submissions

🕒 Junho 3

🌽 Illinois – Remoto

🌽 Illinois – Remote

💵 $110.000 - $150.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Tempus AI

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2015

🧬 Biotecnologia

🤖 Inteligência Artificial

Healthcare • Biotechnology • Artificial Intelligence

A Tempus AI é uma empresa de tecnologia avançada em saúde que se especializa em medicina de precisão através do uso de IA e perfil genômico. A empresa oferece soluções inovadoras em diversos campos médicos, incluindo oncologia, cardiologia, neurologia e psiquiatria. A Tempus permite que os profissionais de saúde tomem decisões informadas sobre tratamentos integrando dados do mundo real, pareamento de ensaios clínicos e testes algorítmicos para melhorar os resultados dos pacientes e acelerar o desenvolvimento de medicamentos.

Descrição

• Developing and leading global regulatory strategies to support business objectives • Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale • Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records • Work closely with business leadership to ensure regulatory strategy aligns with commercial goals • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

🎯 Requisitos

• Oncology IVD, IUO, and CDx experience required • Experience with complex medical devices, such as some combination of: Genomics NGS Software and artificial intelligence based devices Clinical decision support software Oncology • Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR • Software validation and risk management • Cybersecurity in medical devices • Machine learning validation requirements • Lifecycle management of medical devices/IVDs • Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions • Relevant sections of 21 CFR 820/ISO 13485, 21 CFR 812, CAP/CLIA • Strong communication, presentation. and interpersonal skills • Guiding cross-functional teams of subject matter experts • Working in a startup-like environment • Interacting with regulators • Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas • Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs • Excellent attention to detail • Strong project management skills and the ability to execute on project plans in a fast-paced environment • Scientific background PhD preferred. • Minimum of 5+ years of experience in Regulatory Affairs experience related to medical devices • Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans.

🏖️ Benefícios

• incentive compensation • restricted stock units • medical and other benefits depending on the position