Fda jobs in delaware

Remote

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6d ago

POSITION TITLE:Information Technology Specialist - FDA LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions. In our Emerging Technology Lab, innovation drive

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Contract

Depends on Experience

Senior Android Developer

Remote

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6d ago

HiAssociate, Greetingsfor theday, We have a position as aSenior Android Engineerrole forRemote.Please find the job description below for this position. Role:Senior Android Engineer Location: Remote Duration: 24 Months Note: Healthcare or Medical Device experience is mandatory. Key Responsibilities: Triage and debug field issues reported by users of our Android applications. Analyze crash reports, logs, and other diagnostic data to identify the root cause of issues. Develop understanding of ex

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Contract

Depends on Experience

SAP QM Architect

Remote

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26d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Contract

Depends on Experience

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Auditor

Remote or Chicago, Illinois

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Yesterday

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

QA Test Engineer

Remote

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24d ago

Blu Omega is seeking a QA Test Engineer to support a federal program focused on data validation and workflow testing within the FDAs Regulated Product Submission (RPS) program. This role operates in a remote environment and is responsible for executing functional, integration, and data verification tests. The position requires experience supporting testing efforts in a mission-driven environment, with a focus on data accuracy, integrity, and consistency. Program Overview Program: FDA Regulated P

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Full-time

125,000 - 135,000

CMC Regulatory Affairs Consultant

Wilmington, Delaware

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5d ago

CMC Regulatory Affairs ConsultantJob Type: Contract 12 Months Location: Wilmington, DE Hybrid/Onsite Work Arrangement: 3 Days Onsite per Week Non-Negotiable Required QualificationsBachelor''s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.Experience supporting large molecules and/or small molecules.Experience wit

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Contract, Third Party

Depends on Experience

Senior Test Method Validation (TMV) Subject Matter Expert (SME) / Lead

Delaware City, Delaware

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13d ago

Less of a LEAD and MORE of an SME Hands On Senior Level Subject Matter Expert ONSITE Title: TMV Engineer SME Daily duties of the contractor: TMV Engineer/specialist Key Requirement and experience: Develop and validate test methods for complex electromechanical medical device systems to verify essential clinical and system performance requirements. Demonstrate expertise in converting design and clinical requirements into repeatable, reproducible, and validation-ready test methods, including de

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Contract

$50 - $55

Clinical Information Specialist with Womens Health Clinical Practice (W2 ONLY)

Remote

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2d ago

Clinical Information Specialist / W2 ONLY / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experienced Clinical Information Specialist with at least 5 years of experience, in Women s Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Pra

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Contract

Depends on Experience

SAP Security Consultant - Remote

Remote

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4d ago

Title: SAP Security Consultant - Remote Mandatory skills: SAP GRC, AC/PC, SAP BTP Technologies, enterprise-wide system solutions, SAP Security Role Design, user administration, SAP security requirements, SOX, FDA validation, SAP authorization management, SHS compliance requirements, SAP Audit Management, SAP ECC, S/4 HANA, SAP HANA, SAP BI NetWeaver, Fiori, SAP RISE, SAP GTS, SAP NFP, SAP MES, SAP BI systems, supporting tools, Security Weaver, SHARP, SAP role management, SAP Identity Management,

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Contract

52 - 57

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Clinical Information Specialist

Remote

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2d ago

Clinical Information Specialist / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experiencedClinical Information Specialist with at least 5 years of experience, in Womens Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Practice Registe

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Contract

70 - 80

SME - Reviewer Scientist

Remote

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5d ago

Subject Matter Expert - Reviewer ScientistThe SME - Reviewer Scientist will provide scientific and regulatory expertise in reviewing clinical and nonclinical data submitted in support of drug applications. This position will support projects within the FDA Center for Drug Evaluation and Research (CDER), Office of Computational Science, under the direction of the COR. Responsibilities: Review clinical safety and efficacy studies submitted in support of drug applications. Evaluate clinical and non

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Full-time

Depends on Experience

SAP BRH Functional / Support Lead

Remote

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2d ago

Job Summary: Seeking a Senior SAP Batch Release Hub (BRH) Functional/Support Lead with strong SAP BRH and S/4HANA QM expertise to support implementation, production sustainment, hyper care, and go-live activities in a regulated Life Sciences environment. Key Responsibilities Lead SAP BRH implementation, design, and production support. Handle P1/P2 incidents, RCA, defect resolution, integration troubleshooting, and hypercare. Support S/4HANA QM, including batch management, inspection lots, usage

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Contract

Depends on Experience

Splunk Monitoring & Observability Architect

Remote

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24d ago

Job Role: Monitoring & Observability Architect (with focus on Splunk) Location: Canada/USA- Remote No of position: 1 Exp. Start date: 2nd week of Aug Year of Experience: 12-15 Years Type: Fulltime only Role overview: Design, implement, and operate scalable observability platforms to provide metrics, logs, traces, and alerts for cloud-native, distributed systems. Responsibilities Build and maintain Observability pipelines and dashboards (metrics, logs, traces).Define and track SLOs, SLIs, and SLA

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Full-time

$140,000 - $160,000

Micro Contamination Investigator

Remote

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12d ago

Arthur Lawrence is looking for a Micro Contamination Investigator, one of our clients. This is a project-based, remote opportunity. Please find the job description below and send us your updated resume if interested: Must-Have Skills:8+ years of microbiology experience in a pharmaceutical, biologics, medical device, or regulated manufacturing environment. Strong experience with contamination investigations, environmental monitoring, aseptic processing, RCA, CAPA, and technical deviation report

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Contract, Third Party

Depends on Experience

Product Quality Engineer 1

Newark, Delaware

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Today

Job Description Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Works with cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Own Investigations and associated root cause analysis, in

Full-time

USD 54,900.00 - 86,000.00 per year

Senior Software Test Development Engineer - Remote

Remote or San Diego, California

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Today

Genesis10 is currently seeking a Senior Software Test Development Engineer - Remote for a contract position with a Global Medical Technology Company located in San Diego, CA. This is a 12+ month contract opportunity. This position is 100% remote. Compensation: $58.00 - $68.00 per hour, W2, based on qualifications Position Overview: This role involves executing and developing test cases and interfaces to validate firmware for next-generation Continuous Glucose Monitoring (CGM) transmitters. The

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Full-time

Compensation information provided in the description

Product Quality Engineer 2

Newark, Delaware

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Today

Job Description Provide product quality engineering support for on-market medical devices. This role will be responsible for performing evaluations, investigation, risk assessment and root cause analysis in relation to post market feedback and complaints from the field. Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations. Essential Duties and Responsibilities Provide input in prioritization of complaints and investigation

Full-time

USD 78,000.00 - 122,100.00 per year

Fda jobs in Delaware, USA