fda Jobs in baltimore, md

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Senior UX Designer, Product Development - Medical Devices/FDA

One IT Corp

•

Remote

Contract

Senior UX Designer, Product Development Duration: 12+Months Required Location: Remote with travel to Naples, FL once a Quarter PAID FOR BY THE CLIENT. Opportunity Type: Contract-to-Hire A senior UX Designer with Recent Medical device experience and a recent Portfolio. Candidates must have experience working within FDA-regulated environments or equivalent. interfaces for products governed by FDA, ISO 13485, IEC 62304, or similar standards. Must have experience designing for FDA-regulated or equ
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Posted 6 days ago

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Design/Build Solutions to meet our Clients
Posted 14 hours ago | Updated 7 hours ago

Sr Mechanical/Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Jobot

•

US

Full-time

Sr Mechanical/Process Design Engineer - Technical Lead (Cleanrooms/Pharma/Healthcare/cGMP) - Remote (East Coast Preferred) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: Full-Service Engineering Consulting Firm with a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, Des
Posted 1 day ago | Updated 7 hours ago

IBM Maximo EAM Specialist

Transcend IT Solutions

•

Remote

Contract, Third Party

Position Title: IBM Maximo EAM Specialist Location: 100% Remote (East Coast is preferred,Duration: 6+ Months Job Details:MUST HAVE PAST THERMO FISHER EXPERIENCE! Maximo Experience is not the only key skill sets for the positions. Experience in Pharma/ Bio Tech is a MUST Maximo Life Science Industry Solution ExpertiseFDA regulatory experiencePharma validation, change managed, calibration data sheets for life sciencesSignature reference using FDA guidelinesGMP experienceTFS key application experie
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Posted 11 hours ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 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 Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 12 days ago | Updated 5 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

•

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated 5 hours ago

Quality Assurance Specialist-Core Laboratory

Johns Hopkins Medicine

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Baltimore, Maryland, USA

Full-time

The Johns Hopkins Hospital is a world-renowned leader in patient care, serving the greater Baltimore community and patients from all across the globe. Our friendly and knowledgeable staff teams provide support throughout our many specialty departments and centers, from primary visits to emergency care. What Awaits You? Career growth and development Tuition Assistance Diverse and collaborative working environment Affordable and comprehensive benefits package Location: Johns Hopkins Hospital, B
Posted 3 hours ago

Remote Senior Appian Developer

Computer Merchant, Ltd., The

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Remote or Rockville, Maryland, USA

Full-time

JOB TITLE: Senior Appian Developer JOB LOCATION: Remote WAGE RANGE*: $75HR TO $80HR JOB NUMBER: 25-02929 REQUIRED EXPERIENCE: MUST OBTAIN A PUBLIC TRUST Skills: Appian BPM, Application Design, Software Development Experience: 10 + years of related experience JOB DESCRIPTION The Food and Drug Administration (FDA) is the federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devic
Posted 60+ days ago | Updated 7 hours ago

Data Science/ML Engineer

People Force Consulting Inc

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Remote

Contract

We are seeking a highly skilled Senior Machine Learning Engineer to join the Foundational Data Analytics (FDA) Program, a strategic initiative focused on building a modern, intelligent data ecosystem. This role will lead the design, development, and deployment of machine learning models that support enterprise-wide analytics, predictive insights, and healthcare transformation. FDA Program Objectives: Single Source of Truth (SSOT): Build standardized, high-quality data infrastructure ensuring con
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Posted 12 days ago | Updated 4 hours ago

Statistical Programmer

Georgia IT

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Remote

Contract

Job Title: Statistical Programmer Location: Remote Key Responsibilities Develop, validate, and maintain SAS programs for statistical analysis, regulatory submission, and reporting deliverables. Create analysis datasets (ADaM) and tables, listings, and figures (TLFs) for clinical trial data analysis. Collaborate with statisticians and data managers to define specifications for datasets and statistical outputs. Ensure compliance with CDISC standards, internal SOPs, and regulatory guidelines (FDA,
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Posted 10 days ago

Senior Biostatistician: Pharma experience / Remote

Biogensys

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Remote

Contract

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis
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Posted 13 days ago

Regulatory CMS Senior Manager

Sureminds Solutions

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Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig
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Posted 7 days ago | Updated 6 days ago

Senior Outcomes Specialist

E-Solutions, Inc.

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California, USA

Third Party

Job title: Senior Outcomes Specialist Location: Remote Mandatory Skills: SQL, SAS, R, or Python, Healthcare What's in it for you :- We are seeking a results-driven and analytical Senior Outcomes Specialist to support the Foundational Data Analytics (FDA) Program. This role will focus on measuring, analyzing, and improving clinical, operational, and financial outcomes across the enterprise. The ideal candidate will bring deep expertise in healthcare analytics, outcomes measurement, and perfor
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Posted 7 days ago | Updated 9 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Contract, Third Party

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 21 days ago

IRT Auditor

I.T. Solutions

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Remote

Contract

Role: IRT Auditor Location: Remote Type: Contract Length: 6 months Position Summary: We are seeking an experienced Oncology QA Auditor with a strong background in clinical quality assurance and a solid understanding of AI-driven technologies used in clinical trials. This role is essential to ensuring compliance across oncology programs that leverage artificial intelligence and machine learning (AI/ML) tools for clinical decision support, trial optimization, and real-world data interpretation.
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Posted 2 days ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 18 days ago | Updated 10 hours ago

Product Acceptance Engineer - Remote

Stryker

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Remote or Mahwah, New Jersey, USA

Full-time

Work Flexibility: Remote Product Acceptance Engineer - Remote Stryker is hiring a Product Acceptance Engineer to act as the primary liaison between Quality Assurance and Operations within the Finished Goods Operations team. In this role, you will provide expert QA and scientific support to help achieve operational goals. You will also be responsible for ensuring sterility compliance of medical devices in accordance with regulatory standards, leading the testing, monitoring, and validation of c
Posted 22 hours ago | Updated 10 hours ago

Sr. Toxicology Associate Remote

Generis TEK Inc.

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Remote or Racine, Wisconsin, USA

Contract

We have Contract role Sr. Toxicology Associate-Remote for our client at Racine WI. Please let me know if you or any of your friends would be interested in this position. Position Details: Sr. Toxicology Associate-Remote-Racine WI Location : Racine, WI 53403 (Remote) Project Duration : 10+ Months Contract REQUIRED EDUCATION: PhD or Master s degree in toxicology or a related field TOP 5 REQUIRED SKILLS: 1. 4+ years of human health risk assessment experience 2. Proficiency in toxicity study proto
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Posted 3 days ago | Updated moments ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical
Posted 14 days ago | Updated 10 hours ago

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye
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Posted 27 days ago | Updated 18 days ago