International Regulatory Associate
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:
- Support Tempus’ expansion into Europe through our planning through European regulation changes and updates to include new assays into our offering
- Draft and update standard operating procedures to support the implementation of IVDR
- Review product labels and IFUs compliant to IVDR
- Define and limit project scope to closing gaps. Gap closures will require various layers of research, scoping, documentation updates/creation, and more.
- Predict and request resources needed to reach objectives
- Manage a detailed project schedule and work plan; monitor progress and make adjustments as needed
- Identify, prioritize and mitigate project risks.
- Manage resources across various departments as input is required from across the business
- Provide project updates on a consistent basis to various senior stakeholders about strategy, adjustments, and progress
- Ability to push and pivot from plan when needed in order to meet deadlines
Requirements:
- Bachelor’s Degree
- Minimum 2 years’ experience in regulatory affairs in the device/diagnostic industry.
Preferred Qualifications:
- IVDR/MDR experience a plus
- Scientific background in molecular biology and/or NGS
- Demonstrated ability to interpret and implement new regulations
- Working knowledge of EU in vitro diagnostic or medical device regulatory requirements and quality system standards
- Experience with CE mark (EU 2017/745, 2017/746), FDA’s 21 CFR 820 QSR and ISO 13485 quality system requirements
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