International Regulatory Associate

| Chicago
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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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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • GolangLanguages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • SqlLanguages
    • GCPLanguages
    • ReactLibraries
    • ReduxLibraries
    • Node.jsFrameworks
    • SparkFrameworks
    • TensorFlowFrameworks
    • Microsoft SQL ServerDatabases
    • MySQLDatabases
    • PostgreSQLDatabases
    • SQLiteDatabases
    • tableuAnalytics
    • JIRAManagement
    • SalesforceCRM

Location

River North is a lively neighborhood in the Near North Side.

An Insider's view of Tempus

What makes someone successful on your team?

We value creativity in ideation, autonomy in execution, and a healthy tendency to always question the status quo.

Ash

Lead Data Scientist

What are Tempus Perks + Benefits

Tempus Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Mental Health Support Platform
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
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Pair programming
Open office floor plan
Diversity
Highly diverse management team
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Onsite Gym
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Match charitable contributions
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Volunteer Time
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Stocked Kitchen
Some Meals Provided
Happy Hours
Parking
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Promote from within
Mentorship program
Time allotted for learning

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