Are you passionate about using technology to improve the lives of patients?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. 

We are looking for a motivated, optimistic and ambitious candidate to join our quality assurance  team and our efforts to grow Tempus’ international presence. 

The role’s primary responsibility is to support  the organization’s mission of maintaining regulatory compliance helping to assist obtaining business goals of efficiently bringing new innovations and products to the International markets. 

This role reports to the Regulatory Compliance Manager. 

What You’ll Do:

• Assist with certifications and self-certifications process of various Tempus products including CE-mark and IVDR regulatory process 
• Completions of Technical Dossiers
• Identity self certification or notified body certification path of products
• Assist with completion of Declaration of Conformity (EC DoC) of products
• Communication with Tempus’ Notified Body as needed
• Collaborate cross-functionally with Quality, Regulatory, R&D, Engineering, Supply Chain and Operations for continued  support of International Regulatory Compliance, maintenance and improvement of the Quality Management System (QMS).
• Support Lead Auditor with audit functions
• May be required to participate in conducting internal audits under the direction of the Lead Auditor
• Assist with completion of partnership pre qualification questionnaires
• Oversee drafting of internal and external audit responses to closure
• Administrative audit functions as needed
• Comply with documented Quality Management System procedures
• Completion of assigned training on time
• Perform other duties and projects as assigned
• Review QMS documentation against applicable regulations for international compliance
• Remain up to date with applicable  regulations to communicate changing requirements to Management
• Assist with inspection readiness efforts and external audits
• Offer improvement strategies to existing processes

Qualifications:

• Bachelor’s degree required preferably in a life science discipline
• Minimum of 4 years of QMS experience in the  FDA regulated industry - medical devices or IVDs
• Experience with CE mark (EU 2017/745, 2017/746), FDA’s 21 CFR 820 QSR and ISO 13485 quality system requirements
• Some QA experience in a molecular testing laboratory (LDTs) is a plus
• Superb organizational and follow through skills 
• Strong interpersonal skills in the areas of written and verbal communication
• Must be creative, flexible, and able to prioritize and handle multiple projects concurrently
• Must be self-motivated and have the ability to work with minimal supervision
• Prior Quality Management System audit experience preferred
• Interest in obtaining Auditor certification is a plus

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