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Senior Manager/Associate Director of Regulatory Affairs

TempusChicago, Illinois, United StatesOnsite
This job is no longer open

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.

Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine. 

Responsibilities 


  • Developing and leading global regulatory strategies to support business objectives
  • Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc.
  • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale 
  • Developing and executing premarket and postmarket regulatory project plans and strategies 
  • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications 
  • Work closely with business leadership to ensure regulatory strategy aligns with commercial goals 
  • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently 

What your background might look like 


  • Experience with complex medical devices, such as some combination of:
  • Software and artificial intelligence based devices
  • Clinical decision support software
  • Medical imaging
  • Oncology
  • Cardiology
  • Experience with:
  • Premarket Approval (PMA) applications, de novo requests for reclassification, 510(k)s, investigational device exemption (IDE) requirements
  • Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR
  • Software validation and risk management
  • Cybersecurity in medical devices
  • Machine learning validation requirements
  • Changes to medical devices that trigger reporting or regulatory submissions
  • Relevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards
  • Strong communication, presentation and interpersonal skills
  • Experience leading cross-functional teams of subject matter experts
  • Experience working in a startup-like environment
  • Experience interacting with regulators
  • Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas
  • 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 7+ years of experience in Regulatory Affairs experience related to medical devices
  • Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans

#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.

This job is no longer open

Life at Tempus

Tempus helps corporate clients navigate global currency markets by combining unparalleled market insight, competitive rates of exchange and unmatched personalized service. We serve thousands of corporate clients by offering these key differentiated features:
Thrive Here & What We Value1. Collaborative Mindset: The company culture at Tempus emphasizes teamwork and collaboration, as seen through the Sales Representative's focus on cross-functional relationships to achieve work goals.2. Innovation and Technology: Tempus values innovation in genomic data usage and advanced technology implementation for improving patient care.3. Integrity and Trust: The company upholds integrity, respect, and trust as core values in all interactions with clients and colleagues.4. Commitment to Quality Care: A strong focus on delivering critical information about the right treatments at the right time for patients demonstrates a commitment to quality care.5. Salesforce Effectiveness: The company encourages sales force effectiveness, as seen through the emphasis on driving results and promoting a culture of compliance within the organization.6. Cross-functional Collaboration: Tempus fosters collaboration across various teams, including oncology and neuropsychiatry clinician-facing sales teams.7. Equal Opportunity Employer: The company is committed to providing equal opportunities for all employees regardless of their background or identity.8. Advanced Communication Skills: Tempus values strong communication skills, as demonstrated by the Sales Representative's advanced presentation and business acumen.9. Passion for Precision Medicine: A passionate commitment to advancing precision medicine in healthcare is a key aspect of the company culture at Tempus.10. Real-time Insights Delivery: The focus on delivering real-time, actionable insights to physicians highlights the importance of timely and relevant information sharing within the organization.
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