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.
As Tempus expands into applying artificial intelligence to new areas of healthcare we are continuously seeking top talent who are inspired by our purpose to bring therapies to patients that significantly improve their lives. Tempus seeks an experienced, passionate, and dynamic individual to fill this Regulatory Affairs position. This role will involve hands-on work in regulatory submissions with direct impact on our customers and the business. Title and responsibilities will be linked to experience.
- Work in close collaboration with other departments and functions, including Laboratory, Quality, Research & Development, and Clinical to support regulatory objectives while optimizing overall operational efficiency and effectiveness
- Prepare and support submissions, such as 510(k)s, PMAs, Q-subs, and IDEs, for FDA and other regulatory authorities
You can also expect to:
- Provide guidance to project teams in interpreting current US and foreign governmental regulations, agency guidelines, and internal/corporate policies
- Support audits and inspections
- Support regulatory compliance activities
You will have the opportunity to:
- Improve patient outcomes
- Meaningfully impact the company’s short-term and long-term success
- Work closely with senior stakeholders across the organization
- Grow your role
- Create an inspiring and productive workplace
- This position requires 2-5 years related experience in the medical device (including diagnostics) and/or pharmaceutical industry, including experience preparing submissions for regulatory agencies
- Be a high energy, results-oriented contributor with excellent collaboration and project management skills
- Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas
- Willingness to do what it takes
Required Education and Experience:
- Degree in a scientific/technical discipline
- Ability to fluently read, write, and speak in English