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Fda Project Jobs in Broadview, IL (NOW HIRING)

Baxter

Project Manager, R&D

Deerfield, IL

$120K - $165K/yr

Lead teams in defining project strategies, establishing goals, and ensuring project scope is ... Familiarity with FDA regulatory pathways (e.g., 510(k), combination products). * Proven ability to ...

CAI

Data Center Commissioning Project Manager

Chicago, IL · On-site

$128K - $150K/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 ...

Ferrara

Sr. Specialist, Regulatory

Chicago, IL · On-site

$80K - $112K/yr

Advanced knowledge of 21 CFR FDA food and DSHEA regulations and high level of comfort with regulatory interpretation. * Strong knowledge of Kosher, Non-GMO project Verified, Gluten-Free Certified ...

Actalent

Regulatory Scientist

Chicago, IL · On-site

$36.06 - $48.08/hr

... Project Management, Legal, and Quality teams, providing support as needed. This role offers ... Keep up-to-date with FDA regulations and assess their impact on product labeling. * Provide ...

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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 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

Regulatory Affairs Manager

Kobayashi Healthcare International

Niles, IL • On-site

Other

Re-posted 1 hour ago

Job description

The significant responsibilities of the position are listed below. To perform the job successfully, the individual must be able to execute each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other duties, assignments and specific projects may be assigned at the discretion of management.
Duties and Responsibilities
Regulatory Strategy & Compliance
  • Develop and implement regulatory strategies for OTC monograph drug products, cosmetics, dietary supplements, and Class I medical devices.
  • Interpret and apply applicable FDA regulations, guidance documents, enforcement policies, and industry standards.
  • Assess regulatory impact of new product concepts, formulations, claims, labeling, and packaging.
  • Ensure ongoing compliance with FDA requirements and applicable state regulations.

Product Development Support
  • Partner with R&D, Marketing, and Quality teams during product development and commercialization.
  • Review product formulations, ingredients, specifications, and labeling for regulatory compliance.
  • Provide regulatory guidance on product claims, advertising, promotional materials, websites, and digital content.
  • Support innovation initiatives by identifying regulatory pathways and requirements for new products.

Labeling & Claims Review
  • Lead regulatory review and approval of product labels, packaging artwork, instructions for use, and promotional materials.
  • Evaluate structure/function claims, cosmetic claims, OTC drug claims, and device-related claims.
  • Ensure labeling complies with applicable FDA regulations and industry standards.

Regulatory Documentation & Submissions
  • Prepare and maintain regulatory documentation and compliance records.
  • Support FDA registrations, product listings, establishment registrations, and related regulatory filings as required.

Quality & Risk Management
  • Collaborate with Quality Assurance to support audits, inspections, investigations, CAPAs, and change control activities.
  • Assess regulatory risks and provide mitigation strategies.
  • Monitor and communicate regulatory changes that may impact existing or future products.

Cross-Functional Leadership
  • Serve as the primary regulatory resource for internal stakeholders.
  • Provide training and guidance on regulatory requirements and compliance best practices.
  • Support supplier qualification, ingredient reviews, and regulatory due diligence activities.

Post-Market Surveillance & Adverse Event Reporting
  • Manage and oversee adverse event reporting programs for OTC drug products, dietary supplements, cosmetics, and medical devices in accordance with FDA requirements.
  • Evaluate consumer complaints, adverse events, and safety reports for reportability and regulatory impact.
  • Ensure timely submission of required reports, including Serious Adverse Event Reports (SAERs), Medical Device Reports (MDRs), and other applicable regulatory notifications.
  • Partner with Quality, Consumer Relations, and Legal teams to investigate product complaints and safety signals.
  • Maintain adverse event documentation, complaint files, and post-market surveillance records in compliance with applicable regulations.
  • Monitor product safety trends and recommend corrective and preventive actions when necessary.

Support regulatory inspections, audits, and inquiries related to post-market surveillance and adverse event reporting.
Knowledge, Skills & Abilities
  • Strong understanding of FDA regulatory frameworks and enforcement trends.
  • Excellent analytical and risk assessment capabilities.
  • Ability to interpret complex regulations and translate them into practical business guidance.
  • Strong project management and organizational skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects in a fast-paced environment.
  • Collaborative leadership style with strong stakeholder management skills.

Required Qualifications:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or a related field.
  • 5+ years of regulatory affairs experience in FDA-regulated consumer healthcare products.
  • Demonstrated experience with OTC monograph drug products, cosmetics, dietary supplements, and/or medical devices.
  • Strong knowledge of:
    • FDA OTC Monograph regulations
    • FD&C Act requirements
    • Dietary Supplement Health and Education Act (DSHEA)
    • Cosmetic regulatory requirements under MoCRA
    • Class I Medical Device regulations
    • Product labeling and claims compliance
    • cGMP requirements
  • Preferred Qualifications:
  • Advanced degree in scientific discipline, regulatory affairs, or related field.
  • Regulatory Affairs Certification (RAC).
  • Experience working with contract manufacturers and private label products.
  • Experience supporting FDA inspections and regulatory audits.
  • Experience managing adverse event reporting, complaint handling, and post-market surveillance programs for FDA-regulated products.
  • Working knowledge of FDA requirements for Serious Adverse Event Reporting (SAER), Medical Device Reporting (MDR), and cosmetic adverse event reporting requirements under MoCRA.
  • Experience conducting regulatory assessments of consumer complaints, product safety issues, and reportable events.

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