FDA jobs in Wisconsin

Waukesha, Wisconsin

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10d ago

Job Summary: Join an exciting new product development team where our mission is to send mothers and infants home healthy. The incumbent will be a core member of the MIC HW team designing cable harnessing, collaborating and managing suppliers, and carrying out the verification of medical devices. This role will contribute to the overall design, development, and validation of new electromechanical systems, ensuring compliance with FDA regulations and industry standards. The ideal candidate would

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Contract

Depends on Experience

Sr JD Edwards Developer

Remote

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5d ago

Sr. JD Edwards (JDE) Developer / Remote / Contract About our Customer and Role: Our premium customer, a global Fortune 500 company & a leader in the Food Services industry is looking for a Sr JD Edwards Developer for designing, developing, implementing, and supporting custom solutions within the JD Edwards (JDE) EnterpriseOne environment. Responsibilities: Design & Development Develop, enhance, and maintain custom applications, modules, and interfaces within JD Edwards EnterpriseOne.Support & M

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Contract

Depends on Experience

Commercialization & Validation Engineer

Remote or Hybrid

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Today

The CSA Validation SME is a key stakeholder within the ELC CSA Center of Excellence (COE). This role ensures the integrity of CSA projects with a strong focus on risk assessment, compliance, and regulatory adherence. Acting as a subject matter expert (SME), the CSA Validation SME serves as a bridge between COE leadership, protocol authors, and testers. The SME will ensure projects meet regulatory, data integrity, and organizational (R&D/GSC/IT) policies while maintaining best practices in valida

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Contract

$70 - $75 per hour

*Sr. JD Edwards Developer* W2 Role

Remote

•

Today

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of our listed client. Below are the position details Job

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Contract, Third Party

Depends on Experience

(100% REMOTE) Regulatory Affairs Reviewer Promotional Materials- 15 hours a week

Remote

•

Today

Degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.5 years experience in Regulatory Affairs advertising & promotion (ad promo) review or equivalent compliance function with overall RA experience of 10+ years.Strong knowledge of global and regional regulations governing promotional materials (e.g., FDA, EMA, IFPMA, local codes).Excellent attention to detail and ability to balance business needs with regulatory compliance.Strong communication skills to influence and guide cro

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Part-time

$80 - $100

Remote-Sr Business Analyst with Lifesciences client - CRM experience

Remote

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Today

Location: - Remote work but client would prefer candidates from New Jersey.Candidates should be authorized to work in the United States. Educational Qualifications: - Engineering Degree BE/ME/BTech/MTech/BSc/MSc.Technical certification in multiple technologies is desirable. The Senior Business Analyst Pharmaceutical is a pivotal client-facing role responsible for driving business transformation initiatives within leading pharmaceutical companies. This position requires deep expertise in FDA reg

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Third Party, Contract

Depends on Experience

Product Owner

Remote or Hybrid in Pittsburgh, Pennsylvania

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Today

Company Overview: Req ID: 339286 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Product Owner to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). REMOTEJob Description: About the Role We are seeking a highly motivated and experienced Product Owner to support projects within the Heal

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Contract

BASED ON EXPERIENCE

Full Stack Engineer

Remote

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7d ago

Full Stack Engineer - Remote (EST)Responsibilities Collaborate with your team to design, develop, test, deploy, and maintain secure, compliant SaaS solutions Build and enhance software features to address customer challenges and improve user experience Drive continuous improvement efforts and support CI/CD processes throughout the development lifecycle Promote and implement automation to streamline workflows, reduce manual effort, and ensure consistency Engage in all stages of product deve

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Full-time

$135000

Salesforce & TrackWise Digital Solution Architect

Remote

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3d ago

Position: Salesforce & TrackWise Digital Solution ArchitectLocation: RemoteType: Contract / Full-time Job SummaryWe are seeking an experienced Salesforce & TrackWise Digital Solution Architect to lead the end-to-end design and implementation of scalable, compliant, and high-performance digital quality systems. The ideal candidate will bring strong expertise in solution architecture, system integration, and governance for regulated environments (Life Sciences / Pharma preferred). Key Responsibili

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Contract, Third Party

$100,000 - $160,000

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

R&D Quality Partner

Remote

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21d ago

Job Title: R&D Quality Partner Diagnostics & Combination ProductsJob Location: RemoteType: W2/C2CDuration: 6 months (extensions possible)Start Date: ASAP Summary (Short JD):Seeking an R&D Quality Business Partner with strong expertise in diagnostics, medical devices, and drug-device combination products. This role will define and implement an R&D-focused Quality Management System (QMS), ensure compliance with FDA, EMA, ISO 13485/14971, EU IVDR, and 21 CFR regulations, and act as a strategic part

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Contract, Third Party

$35 - $45

Biostatistician/SAS

Remote

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20d ago

Position: Biostatistician -Open Position-HI Type: contract Duration: 12 months Location: Hawai Responsibilities. Write/review SAP and clinical trial protocol; develop and validate complex statistical models and SAS programs for analysis, management & reporting of clinical data. Perform statistical analysis, create and verify clinical trial reports and TLGs to support FDA submission. Req.: Master's degree/equiv. in Biostatistics, Statistics, Public Health or related. Proficiency in clinical dat

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Contract

Depends on Experience

Maintenance Technician

Clyman, Wisconsin

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Today

Job DescriptionJob DescriptionMaintenance Technician Maintenance Electrician Position Overview The Maintenance Technician is responsible for ensuring the optimal performance of manufacturing equipment and systems in a food production environment. This includes troubleshooting, repairing, and maintaining mechanical and electrical systems to ensure compliance with industry standards and regulations. Key Responsibilities Perform routine maintenance and repairs on manufacturing equipment and machin

Full-time

Business Analyst - Pharmacy or PBM experience

Remote

•

Yesterday

Urgently looking to hire Business Analyst- Fulltime or Contract About the Role We are seeking an experienced Business Analyst with a strong background in pharmacy operations or pharmacy benefit management (PBM), or specialty pharmacy products. The Business Analyst will play a critical role in bridging business needs with technical solutions, ensuring that systems and processes align with regulatory requirements and support patient-centered pharmacy services. Key Responsibilities Partner with bus

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Full-time

Depends on Experience

Business Analyst - Lifesciences R&D

Remote

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Today

Business Analyst LifeSciences R&D Job Summary: We are seeking a highly motivated and detail-oriented Business Analyst with expertise in R&D and Life Sciences to support strategic initiatives across the Research & Development function. This role will work closely with cross-functional teams including scientists, clinical teams, regulatory affairs, and IT to drive process improvements, support system implementations, and deliver data-driven insights that enable innovation and regulatory complian

Third Party, Contract

JD Edwards Developer

Remote or Hybrid

•

Today

JD Edwards Developer 100% Remote 12 + Months CTH Pay: $58 - $60/HR Salary: $100K - $115K Overview: Seeking an experienced JDE Senior Developer to design, develop, and support custom solutions within JD Edwards EnterpriseOne. This role involves collaborating with cross-functional teams to deliver optimized ERP solutions aligned with business goals. Key Responsibilities: Develop and maintain custom applications within JD Edwards. Troubleshoot issues, monitor performance, and ensure system reliab

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Contract

$58 - $60 per hour

Salesforce & TrackWise Digital Solution Architect

Remote

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3d ago

Position: Salesforce & TrackWise Digital Solution Architect Location: Remote Job Summary We are seeking an experienced Salesforce & TrackWise Digital Solution Architect to lead the end-to-end design and implementation of scalable, compliant, and high-performance digital quality systems. The ideal candidate will bring strong expertise in solution architecture, system integration, and governance for regulated environments (Life Sciences / Pharma preferred). Key Responsibilities Solution Architectu

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Third Party, Contract

$50 - $60

Sr. Software Engineer

Remote or Salt Lake City, Utah

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Today

Sr. Software Engineer (onsite or remote depending on location) Salt Lake City, UT or Denver, CO Direct Hire Pay: $140k-$160k Job Description: Our client is looking for a Sr. Software Engineer. As part of the team working in R&D, you will work across multiple languages and frameworks, including React Native, React, TypeScript, JavaScript, Python, and AWS (Flutter is a plus). You'll operate within a regulated SDLC (FDA, 62304/82304) emphasizing automation, testing, observability, cybersecurity,

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Full-time

USD 140,000.00 - 160,000.00 per year

Senior .NET Developer with Cloud Expertise

Remote

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4d ago

This is a remote position. Senior .NET Developer - Architect resilient systems at global scale Company: Ajmera Infotech Inc.Experience: 7+ years Location: Remote or Texas (Remote-first with flexibility to work across U.S. time zones) Employment Type: Contract: 1099 (Independent Contractor) About Ajmera Infotech Ajmera Infotech powers mission-critical platforms for NYSE-listed enterprises. With a 120+ engineer team delivering planet-scale systems, our software operates in environments where fai

Contract

40-50 $ per Hrs

Lead Solutions Engineer - Bioinformatics (Remote)

Remote or Lewisville, Texas

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Today

Job Description The Lead Solutions Engineer is responsible for overseeing and leading technical design, implementation and delivery of projects aiming to launch new diagnostic tests and services. The lead solutions engineer acts as the technical owner for bioinformatics in a project, being responsible for the end-to-end solution from technical side. They also engage with the stakeholders of bioinformatics, leading communication and coordinating work, supporting project manager with status of th

Full-time

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FDA jobs in Wisconsin, USA