Global Director of Regulatory Affairs
hace 2 semanas
**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.
At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA and other health authorities. Our Global Director of Regulatory Affairs will work closely with scientists, engineers, clinicians, business leaders, quality professionals, and legal team to support our efforts to advance personalized medicine outside of the United States.
**Responsibilities**
- Handle day to day management of global regulatory activities, including:
- Developing and executing strategies for compliance with regulatory requirements outside of the United States, especially with respect to IVDR, MDR, UKCA
- Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale
- Developing and executing premarket and postmarket regulatory project plans and strategies
- Overseeing the creation and maintenance of device labeling
- Work closely with business leadership to ensure regulatory strategy aligns with business objectives
- Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently, and training staff
**What your background might look like**
- Experience with in vitro diagnostics, including:
- Next generation sequencing
- Companion diagnostics
- Software and artificial intelligence based devices
- Experience with ex-US regulatory issues, such as: CE Marking, UKCA registration, performance studies as required under IVDR and MDR
- Strong communication, presentation and interpersonal skills
- Experience working in a startup-like environment
- Experience interacting with regulators
- Ability to work well with quality, clinical, bioinformatics, and laboratory teams
- 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
- Bachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.
- Minimum of 5+ years of experience in Regulatory Affairs experience related to IVDs/medical devices
- Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans
- Geographical location
- Individual to be located in Europe
**#LI-SH1**:
**#LI-Remote**:
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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