Senior Director/Director of Regulatory Affairs

| Remote
Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.

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 Director/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 10+ 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.

Read Full Job Description
Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.

Technology we use

  • Engineering
  • Product
  • Sales & Marketing
  • People Operations
    • GolangLanguages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • SqlLanguages
    • SwiftLanguages
    • GCPLanguages
    • ReactLibraries
    • ReduxLibraries
    • Node.jsFrameworks
    • SparkFrameworks
    • TensorFlowFrameworks
    • Microsoft SQL ServerDatabases
    • MySQLDatabases
    • PostgreSQLDatabases
    • SQLiteDatabases
    • LookerAnalytics
    • TableauAnalytics
    • FigmaDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • Google SlidesManagement
    • JIRAManagement
    • TrelloManagement
    • DocuSignCRM
    • SalesforceCRM
    • MarketoLead Gen
    • Google HangoutsCollaboration
    • SlackCollaboration
    • ZoomCollaboration

Location

Our New York City office is centrally situated in the heart of Midtown Manhattan, within close proximity to iconic landmarks such as Times Square and Bryant Park. Easily accessible by public transportation, a dynamic cultural scene, and a diverse array of dining establishments in NYC.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

How does the company support your career growth?

I have frequent meetings with my manager, solely about the direction I want to lead my career in. The most amazing part about having these discussions is that the focus is on how Tempus can help me succeed. Having that guidance and motivation is really beneficial.

Patrick

Junior Clinical Data Abstractor

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave Benefits
Generous parental leave
Family medical leave
Vacation & Time Off Benefits
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

More Jobs at Tempus AI

Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.
Learn more about Tempus AIFind similar jobs like this