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Fda Project Jobs in Chicago, IL (NOW HIRING)

Clayco (LJC)

Project Architect - Life Sciences

Chicago, IL

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Clayco

Project Architect - Life Sciences

Chicago, IL · On-site

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Clayco (LJC)

Project Architect - Life Sciences

Chicago, IL

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Clayco (LJC)

Project Architect - Life Sciences

Chicago, IL

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Clayco (LJC)

Project Architect - Life Sciences

Chicago, IL

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Clayco (LJC)

Project Architect - Life Sciences

Chicago, IL

$85K - $114K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Strong understanding of life sciences regulatory requirements, including cGMP, FDA, EU ... Our clients and projects are nationwide * No other builder can offer the collaborative design-build ...

Stark Pharma Solutions Inc

Senior Project Engineer

Chicago, IL · On-site

$102K - $132K/yr

Senior Project Engineer Location: Illinois Duration: Long-Term Job Overview The Senior Project ... Working knowledge of FDA cGMP, OSHA, environmental, building, and fire code requirements. * Strong ...

New

Nestle

Project Engineer

Schaumburg, IL · On-site

  • Medical

  • Retirement

The Project Engineer is responsible for providing technical leadership by identifying, developing ... Monitors processes for compliance with quality and GMP requirements in accordance with FDA and OSHA ...

Horizontal Talent

Sr. Project Manager

Lake Forest, IL · On-site +1

$24 - $55/hr

  • Medical

  • Dental

  • Vision

  • Retirement

Join a dynamic project leadership opportunity supporting a Companion Diagnostic program within a ... Support complex transformational work in a quality-focused, FDA-regulated environment. * Partner ...

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Showing results 1-20

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

Project Engineer

Stark Pharma Solutions Inc

North Chicago, IL • On-site

Contractor

Posted 8 days ago

Job description

Position: Project Engineer
Location: Illinois
Duration: Long Term

Job Overview

We are seeking an experienced Project Engineer to support medical device and combination product development projects. The ideal candidate will lead Use-Related Risk Analysis (URRA), Systems Engineering, and Design Control activities while collaborating with cross-functional teams to ensure successful product development and regulatory compliance.

Key Responsibilities

  • Lead and coordinate Use-Related Risk Analysis (URRA) activities across multiple projects.
  • Facilitate cross-functional meetings to develop and maintain risk management documentation.
  • Collaborate with Human Factors, Quality, Clinical, Manufacturing, and Engineering teams to identify hazards, risks, and mitigation strategies.
  • Develop and maintain Design History Files (DHF) and Design Control documentation.
  • Support Systems Engineering activities, including requirements management, traceability, system architecture, and risk assessments.
  • Perform and review Use-Related Risk Assessments, Design FMEAs, and Process FMEAs.
  • Monitor project schedules, milestones, risks, and deliverables while communicating project status to stakeholders.
  • Support change management, third-party vendor coordination, and Quality by Design (QbD) activities.
  • Ensure compliance with FDA regulations, ISO standards, and medical device quality requirements.

Required Qualifications

  • BS in Engineering, Science, or a related discipline with 10+ years of experience, or MS with 8+ years of relevant experience.
  • 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries.
  • Expertise in Design History File (DHF) management and Design Control documentation.
  • Strong knowledge of Systems Engineering, product development, requirements management, and traceability.
  • Experience with Use-Related Risk Analysis (URRA), Human Factors Engineering, Risk Management, Design FMEA, and Process FMEA.
  • Familiarity with FDA 21 CFR Part 820, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.
  • Experience with project scheduling, document management tools, and vendor management.
  • Excellent analytical, organizational, communication, and cross-functional collaboration skills.