Passionate about precision medicine and advancing the healthcare industry?
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.
Responsibilities:
- 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
- Lead partnership/client audits.
- 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
- Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections.
Required Skills:
- 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
- Minimum of 4 years of QMS experience in the FDA regulated industry - medical devices or IVDs
- Bachelor’s degree required preferably in a life science discipline
Preferred Experience
- Some QA experience in a molecular testing laboratory (LDTs) is a plus
- Interest in obtaining Auditor certification is a plus
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