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Fda Project Jobs in Broadview, IL (NOW HIRING)

Intellectt INC

Sustaining Project Manager

Buffalo Grove, IL · On-site

$116K/yr

Sustaining Project Manager Location: Buffalo Grove, IL Position Summary Seeking an experienced ... Ensure compliance with FDA, GMP, and quality system requirements. * Drive continuous improvement ...

Newly Weds Foods

Engineering Project Manager

Chicago, IL · On-site

$150K - $180K/yr

... 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 ...

Lactalis

Sr. Packaging Project Manager

Chicago, IL · On-site

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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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 Broadview, IL are hiring for Fda Project jobs? Cities near Broadview, IL with the most Fda Project job openings:
Fda Project jobs near you

Sustaining Project Manager

Intellectt INC

Buffalo Grove, IL • On-site

$116K/yr

Contractor

This job post has expired today. Applications are no longer accepted.

Job description

Hello,

I hope you’re doing well.

My name is Vyshu, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Sustaining Project Manager based in Buffalo Grove, IL with one of our prestigious clients.

I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at vyshnavi.t@intellectt.com
 

Title: Sustaining Project Manager
Location: Buffalo Grove, IL
Position Summary
Seeking an experienced Sustaining Project Manager to lead post-launch and lifecycle management projects for medical device products. The role will work closely with Engineering, Manufacturing, Quality, Supply Chain, and Regulatory teams to support product improvements, manufacturing operations, and process optimization in a regulated environment.

Key Responsibilities

  • Manage sustaining and post-launch projects for medical device products.
  • Coordinate cross-functional teams to drive project execution and issue resolution.
  • Support product enhancements, process improvements, and change control activities.
  • Track project schedules, risks, deliverables, and stakeholder communications.
  • Ensure compliance with FDA, GMP, and quality system requirements.
  • Drive continuous improvement and manufacturing optimization initiatives.

Required Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • 5+ years of project management experience in medical device manufacturing.
  • Experience supporting medical device launch and sustaining engineering activities.
  • Strong understanding of manufacturing processes and regulated environments.
  • Excellent leadership, communication, and organizational skills.

Key requirements:

  • Strong Project Management experience
  • 6–8 years of relevant experience
  • Experience working in a manufacturing environment
  • Original Equipment Manufacturing experience is required
  • Experience with line efficiency, downtime reduction, and scrap management


 

Thanks & Regards,
Vyshnavi
Recruiter
Intellectt Inc 
vyshnavi.t@intellectt.com
Direct: 732 204 6550
Desk number: 732 412 6999 - Ext: 225