Manager, Regulatory Submissions

🕒 vor 6 Tagen

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $110.000 - $150.000 / Jahr

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

🚔 Compliance

Jetzt Bewerben

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Tempus AI

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

Gegründet 2015

🧬 Biotechnologie

🤖 Künstliche Intelligenz

Healthcare • Biotechnology • Artificial Intelligence

Tempus AI ist ein fortschrittliches Unternehmen im Gesundheitsbereich, das sich auf Präzisionsmedizin durch den Einsatz von KI und genomischem Profiling spezialisiert hat. Das Unternehmen bietet innovative Lösungen in verschiedenen medizinischen Bereichen, darunter Onkologie, Kardiologie, Neurologie und Psychiatrie. Tempus ermöglicht es Gesundheitsdienstleistern, fundierte Behandlungsentscheidungen zu treffen, indem es reale Daten integriert, klinisches Studiomatching und algorithmische Tests durchführt, um die Patientenergebnisse zu verbessern und die Medikamentenentwicklung zu beschleunigen.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

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