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Fda Project Jobs in Broadview, IL (NOW HIRING)

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 ...

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 ...

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 ...

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 ...

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 ...

Organ Recovery Systems

Project Manager

Itasca, IL · On-site

The Project Manager will lead complex cross-functional initiatives within an FDA-regulated medical device, pharmaceutical, biotechnology, or diagnostics environment. Candidates must have at least 5 ...

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

Nestlé USA

Project Engineer

Schaumburg, IL · On-site

$97K - $117K/yr

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 ...

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 ...

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All JobsFda Project JobsFda Project Jobs in Broadview, 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 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 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 qualifications do you need to work for the FDA?

To work as an FDA project professional, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Advanced positions may require a master's degree or higher, along with relevant experience, knowledge of regulatory guidelines, and strong analytical skills. Certifications like Regulatory Affairs Certification (RAC) can also enhance qualifications.

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

Remote Healthcare & FDA Regulatory Law Specialist

Chicago, IL • Remote

Turing
IT Services • 51 - 200 employees
Learn more about Turingexternal

$100 - $200/hr

Contractor

Posted 5 days ago

Job description

About Turing:
Based in San Francisco, California, Turing is the world’s leading research accelerator for frontier AI labs and a trusted partner for global enterprises deploying advanced AI systems. Turing supports customers in two ways: first, by accelerating frontier research with high-quality data, advanced training pipelines, plus top AI researchers who specialize in coding, reasoning, STEM, multilinguality, multimodality, and agents; and second, by applying that expertise to help enterprises transform AI from proof of concept into proprietary intelligence with systems that perform reliably, deliver measurable impact, and drive lasting results on the P&L.

Role Overview:
Turing invites Healthcare and FDA Regulatory Law experts to join projects that fine-tune AI models like ChatGPT. You will apply your expertise in healthcare compliance, FDA drug/device approval, Anti-Kickback Statute analysis, and HIPAA enforcement to evaluate how AI handles healthcare regulatory scenarios. If you enjoy analyzing Stark Law exceptions, False Claims Act liability, and pre-market approval pathways, this is your opportunity. No prior AI experience is required — your background in U.S. healthcare law is exactly what’s needed.

What Does Day-to-Day Look Like:
  • Review and evaluate AI-generated responses to U.S. healthcare law hypotheticals, including HIPAA privacy and security rules, Anti-Kickback Statute safe harbors, Stark Law exceptions, and FDA approval pathways (510(k), PMA, NDA).
  • Apply a structured legal rubric to assess issue spotting, accuracy of healthcare regulations, and proper application of CMS guidance and FDA rules.
  • Identify gaps in AI reasoning around fraud and abuse compliance, clinical trial regulations, telehealth law, and pharmacy benefit management.
  • Provide detailed, high-quality annotations and written feedback to refine AI models.
  • Collaborate with researchers and project managers to align evaluation standards and project goals. 

Requirements:
  • Juris Doctor (J.D.) from an accredited U.S. law school; Bar admission (active/inactive).
  • 3+ years of U.S. legal practice in healthcare law, FDA regulatory affairs, or healthcare compliance.
  • Strong reasoning skills across HIPAA, the Anti-Kickback Statute, Stark Law, False Claims Act, and FDA regulations.
  • Excellent written communication and attention to detail.
  • High ethical standards; interest in AI is a plus.

Perks of Freelancing with Turing:
  • Opportunity to work on cutting-edge AI projects with leading LLM companies.
  • Competitive compensation.
  • Flexible, fully remote work arrangement.
  • Learn how to use AI to advance the legal field.

Offer Details:
  • Commitment: Flexible, 10–30 hrs/week.
  • Duration: ~1 month, with the possibility of extension based on performance and project needs.