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Fda Project Jobs in Broadview, IL (NOW HIRING)

Clayco

Project Architect - Life Sciences

Chicago, IL · On-site

$85K - $114K/yr

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 · On-site

$85K - $114K/yr

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 ...

Nestle

Project Engineer

Schaumburg, IL · On-site

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 ...

CEDENT

Senior Clinical Project Manager

Chicago, IL · On-site

Effectively communicate project-related information including the planning and execution of ... Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulations

Abbott

Sr. Project Manager

Lake Forest, IL · On-site

$55 - $57/hr

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 ...

Intellectt INC

Sustaining Project Manager

Buffalo Grove, IL · On-site

$116K/yr

Sustaining Project Manager Location: Buffalo Grove, IL Position Summary We are seeking an ... Ensure compliance with FDA, GMP, and quality system requirements. * Support continuous improvement ...

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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

NPI Project Manager

Intellectt INC

Buffalo Grove, IL • On-site

$55 - $60/hr

Contractor

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

Job description

Hello,
My name is Bipasa, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a NPI Project Manager based in Libertyville, 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 bipasa.s@intellectt.com
Job Title: NPI Project Manager
Location: Libertyville, IL

Job Summary:
Seeking an experienced NPI Project Manager with 10+ years of medical device manufacturing experience to lead New Product Introduction (NPI) projects from development through product launch. Must have strong experience managing cross-functional teams, manufacturing readiness, product transfers, and FDA/GMP compliance.

Key Responsibilities:

  • Lead end-to-end NPI projects for medical devices.
  • Manage project schedules, risks, budgets, and product launches.
  • Coordinate with Engineering, Manufacturing, Quality, Supply Chain, and Regulatory teams.
  • Support product transfer, process development, and manufacturing scale-up.
  • Ensure compliance with FDA, GMP, and quality standards.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • 10+ years of NPI Project Management experience in medical device manufacturing.
  • Strong knowledge of NPI, product lifecycle, and manufacturing operations.
  • Experience working in FDA/GMP regulated environments.
  • Excellent leadership, communication, and project management skills.