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Fda Project Jobs in Chicago, IL (NOW HIRING)

Abbott

Sr. Project Manager

Lake Forest, IL · On-site

$55 - $57/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Title: Sr. Project Manager Location: Lake Forest, IL Duration: 12 Months 100% Onsite Summary ... R&D, and FDA regulated products. * Proven leadership skills, results oriented, highly ...

CAI

Data Center Project Administrator

Chicago, IL · On-site

$60K - $75K/yr

  • Medical

  • Life

  • PTO

We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...

New

CAI

Data Center Project Administrator

Chicago, IL · On-site

$60K - $75K/yr

  • Medical

  • Life

  • PTO

We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...

New

CAI

Data Center Project Administrator

Chicago, IL · Remote

$60K - $75K/yr

We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...

New

Newly Weds Foods

Engineering Project Manager

Chicago, IL · On-site

$150K - $180K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... as FDA, , BRC, OSHA, EPA, etc. * Works cross-functionally with Finance, Operations, R&D, IT, ... Performs other duties or special projects as needed. Qualifications: * BS or BA in Engineering ...

System One

Senior Information Systems Project Manager

Cary, IL · On-site

$66.66/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Experience delivering projects in regulated environments (FDA, ISO, SOX) * Excellent project management skills including planning and risk management * Strong leadership and accountability for ...

System One

Senior Information Systems Project Manager

Cary, IL · On-site

$66.66/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Experience delivering projects in regulated environments (FDA, ISO, SOX) * Excellent project management skills including planning and risk management * Strong leadership and accountability for ...

System One

Senior Information Systems Project Manager

Cary, IL · On-site

$66.66/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Experience delivering projects in regulated environments (FDA, ISO, SOX) * Excellent project management skills including planning and risk management * Strong leadership and accountability for ...

System One

Senior Information Systems Project Manager

Cary, IL · On-site

$66.66/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Experience delivering projects in regulated environments (FDA, ISO, SOX) * Excellent project management skills including planning and risk management * Strong leadership and accountability for ...

Lactalis

Sr. Packaging Project Manager

Chicago, IL · On-site

  • Retirement

  • PTO

The Sr. Packaging Project Manager is responsible for managing and leading projects related to the ... Minimum of 3 years of USDA or FDA regulated plant experience supporting manufacturing and utilities ...

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Showing results 21-40

All JobsFda Project JobsFda Project Jobs in Chicago, IL

Fda Project information

What is an FDA project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA project manager?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What cities near Chicago, IL are hiring for Fda Project jobs?

Cities near Chicago, IL with the most Fda Project job openings:

Fda Project jobs near you

Sr. Project Manager

Abbott

Lake Forest, IL • On-site

$55 - $57/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted yesterday

Abbott rating

7.8

Company rating: 7.8 out of 10

Based on 138 frontline employees who took The Breakroom Quiz

178th of 540 rated manufacturers

Job description

Title: Sr. Project Manager
Location: Lake Forest, IL
Duration: 12 Months
100% Onsite
Summary:
Responsible for managing 4 or more projects (with supervision) with low to moderate complexity through the complete project lifecycle involving functional teams (both domestic and international) focused on the delivery of new or existing programs.
Main Responsibilities:
  • Accountable for clearly defining and managing total project scope; develop and manage project charter and project plan to meet deliverables. Identify key milestones for project status reporting; complete projects on time and within budget constraints.
  • Manage creation and updates of detailed project plans, resource and budget management, schedule management, project risk assessments, and project documentation.
  • Recognize and integrate the broader implications of actions and proposals on the final project outcomes.
  • Lead cross-functional teams to execute projects, identifying tasks, creating and tracking project schedule with problem solving methodology; identify problems and work with cross-functional team to resolve them
  • Drive teams to meet milestones and deliverables established in project planning and agreed upon with senior leadership.
  • Using advanced excel skills and Power BI, prepare and present data-informed written and oral reports and other presentations to sr. leadership audiences; under supervision, may create and deliver project review presentation to leadership as necessary
  • Track and present budget variances, and recommend contingency options
  • Create a work environment that supports team effectiveness

Qualifications:
  • Bachelors Degree (± 16 years)
  • Relevant experience.

Experience/Background:
  • Minimum 5 years
  • Minimum 5 years project management or related experience, including several years of project Management experience and success in managing complex organization transformational projects.

Licenses and Certifications:
  • Advanced knowledge and application of Word and PowerPoint, Teams and virtual event software; superuser-level Excel knowledge.

Top Skills:
  • Minimum 5 years project management or related experience, including several years of project Management experience and success in managing complex organization transformational projects.
  • This will support the Companion Diagnostic (CDx) program and will interact directly with external partners.
  • Minimum 5 years In medical/biotech industries. Knowledge of regulations and standards of medical devices.
  • 5-10 plus years of service industry experience with companies engaged in the manufacture of high quality, R&D, and FDA regulated products.
  • Proven leadership skills, results oriented, highly collaborative, team player, and self-starter who can operate in a fast pace environment.
  • Management experience in service planning and delivery, documented systems, GMP, and quality.

Consultants Eligible Benefits Upon Waiting Period:
  • Medical and Prescription Drug Plans
  • Dental Plan
  • Vision Plan
  • Health Savings Account (for High-Deductible Health Plans)
  • Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
  • Supplemental Life Insurance
  • Short Term Disability (coverage varies by state)
  • Long Term Disability
  • Critical Illness, Hospital coverage, Accident Insurance
  • MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
  • 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.
  • Published on 15 Jul 2026, 9:08 PM

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