FDA jobs | Dice.com

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

Junior Validation Engineer with CSV / CQV

Cambridge, Massachusetts

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17d ago

Arthur Lawrence is looking for a Junior Validation Engineer with CSV / CQV one our clients in Cambridge MA. Please find the job description below and send us your updated resume if interested: Must-Have Skills: Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements. Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Per

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Contract, Third Party

$30 - $39

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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Today

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

Validation Lead - Raritan, NJ(Hybrid)

Raritan, New Jersey

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4d ago

We are looking for a Validation Lead to join our team. Please review the job description below, and let us know if you are interested and available. If this opportunity matches your experience and career goals, we would love to discuss it more. Additionally, feel free to share your updated resume for consideration Role - Validation LeadLocation Raritan, NJ(Hybrid) Duration: Long Term Contract Rate: $70/HR on C2C Max Must Have - Computer System Validation experience M&A related Data Migration

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Contract, Third Party

60 - 70

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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Contract, Third Party

$100 - $110

Manufacturing Engineer

Pleasanton, California

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2d ago

Position: Manufacturing Engineer Location: Pleasanton, CA Opening: 1 Job Summary: 5+ years of Medical device Manufacturing experience Support in Manufacturing process remediation and readiness activities for new product launch.Support Design Transfer deliverables, including tracking and scheduling.Support/Initiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.Risk Management updates PFMEA.Part

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Third Party, Contract

40 - 45

C++ Developer - Medical Device - Las Gatos, CA

Santa Clara, California

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12d ago

Senior Software Engineer (C++) Location: Los Gatos, CA (On-site) Role Overview Seeking a Senior Software Engineer to play a key role in the design, development, and verification of software for a safety-critical medical device system. This role requires strong technical expertise, attention to quality and regulatory standards, and the ability to collaborate across multidisciplinary teams in a fast-paced startup environment. Key Responsibilities Design, develop, and maintain high-quality softw

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Contract

Depends on Experience

Quality manger

Hybrid in Crystal Lake, Illinois

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12d ago

Role Summary We are seeking an experienced Quality Manager for a manufacturing facility based in Crystal Lake. This role reports directly to the Plant Manager and is responsible for leading the sites Quality Management System, ensuring compliance with ISO standards, and driving continuous improvement across all quality-related functions. The ideal candidate is a hands-on quality leader who can balance strategic oversight with operational execution while building a strong quality culture across t

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Full-time

90,000 - 100,000

Software Quality Assurance Engineer (Medical Device) - Only On W2

Lake Forest, Illinois

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4d ago

Position SummaryThe Software Quality Assurance Engineer will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help

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Contract

35 - 40

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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Third Party, Contract

Depends on Experience

Manufacturing Technician I

Lawrence, Massachusetts

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2d ago

Client LocationCountry: United StatesState/Province: MassachusettsCity: LawrenceAddress: 360 Merrimack Street, Lawrence*LawrencePOSTAL CODE: 01843Duties: Execute consumables manufacturing processes according to established Standard Operating Procedures (SOPs) Maintain strict adherence to quality standards and efficiency metrics Operate in cleanroom environments following contamination control protocols Handle consumable materials with precision under guidance of Group Leaders or trai

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Contract, Third Party

$25 - $25

Regulatory Affairs Specialist 4

Sunnyvale, California

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2d ago

Primary Function of Position The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Essential Job Duties Provide regulatory guidance to product teams, develop regulatory plans, a

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Contract, Third Party

$60 - $60

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

Lab Support IT Administrator

Wilmington, Ohio

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3d ago

Employment Eligibility Statement: Due to specific project and client requirements, this position is open to U.S. Citizens and U.S. Lawful Permanent Residents (Green Card holders). Sponsorship is not available at this time. Danta Technologies evaluates all candidates in compliance with the Immigration and Nationality Act (INA) and EEOC guidelines. All hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, vete

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Contract

$28 - $30

Regulatory & Clinical Affairs Manager

Princeton, New Jersey

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9d ago

Role: Regulatory & Clinical Affairs Manager Locations : Princeton, NJ (Onsite) (Full Time /Permanent) Note* FULLTIME Role and This role is on-site at Princeton, NJ The Role The Regulatory & Clinical Affairs Manager will play a key role in supporting the Company s regulatory and clinical initiatives across product development, regulatory submissions, and hospital collaborations. This position is intended for a motivated professional seeking to grow into increasing levels of responsibility withi

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Full-time

$160,000 - $170,000