FDA Jobs in Maryland

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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 1 day 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 moments 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 2 days ago | Updated moments ago

Business Analyst

NTT DATA Americas, Inc

•

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 6 days ago | Updated moments 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 moments ago

Statistical Programmer

Georgia IT

•

Remote

Contract

Statistical Programmer Remote Duration: 12+ Months Rate: DOE Key responsibilities At least 5 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in production side.Collaborate with statisticians and data managers to define dataset specifications and outputsEnsure compliance with internal SOPs, CDISC standards,
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Posted 6 days ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Third Party, Contract

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 6 days ago | Updated 1 hour ago

Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.

•

Rockville, Maryland, USA

Full-time, Contract

Position Summary : The Proposal Writer / Proposal Development Specialist supports the proposal and business development teams in growth activities. This position involves conducting research, proposal writing and content development. Experience in creating compliant proposal responses to Federal solicitations is required. Candidates should have experience collaborating with various stakeholders to develop win themes and value propositions and providing essential proposal development process su
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Posted 60+ days ago | Updated moments ago

Technical Proposal Solutions Architect

ExpediteInfoTech, Inc.

•

Rockville, Maryland, USA

Full-time, Contract

Summary: As the Technical Proposal Solutions Architect for ExpediteInfoTech, Inc. (EIT), you will lead overall technical solutions for RFIs, RFPs, RFXs, SSNs, including for IDIQs, BPAs, GWACs, Task Order contracts and technical marketing material including white papers. Providing technical strategies, solutions, and forward-looking advisory services are just a few of the exciting responsibilities of this position.The successful candidate will possess a broad base of core technical knowledge and
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Posted 60+ days ago | Updated moments ago

Regulatory Specialist

NavaTech LLC

•

Maryland, USA

Third Party, Contract

Regulatory Specialist Location: Hybrid: 2 4 Days Onsite presence required in Leesburg or Tysons, VA (Subject to change) This is a contract-to-hire position. Job Description: Regulatory Affairs Specialist with a strong understanding of FDA regulatory processes for drugs, medical devices, or both. The ideal candidate will serve as a Subject Matter Expert (SME), offering in-depth guidance on the end-to-end regulatory lifecycle, including pre-submission planning, documentation requirements, and f
Posted 13 days ago | Updated 2 hours ago

Technical Lead AWS

Trigent Solutions

•

Remote

Full-time

Job Title: Technical Lead AWS (AI/ML Experience Preferred) Client: U.S. Food and Drug Administration (FDA) Position Type: Full-time | Permanent Location: 100% Remote Job Summary: We are seeking a highly skilled Technical Lead to support our ongoing initiatives with the FDA. The ideal candidate will have a strong technical background, leadership experience, and a passion for innovation, with machine learning (AI/ML) experience being a strong plus. This is a long-term, fully remote opportunity wi
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Posted 2 days ago

Senior Biostatistician

Georgia IT

•

Remote

Contract

Senior Biostatistician Remote Duration: 12+ Months Rate: DOE At least 8years of experienceIn Addition to the above Statistical Programming II 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 analysisMentor junior biostatisticians and support team developmentEnsure compliance with industry standards (CDISC, ICH, FDA/EMA gu
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Posted 6 days 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 6 days ago | Updated 3 hours ago

Statistical Programmer

Georgia IT

•

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 5 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 7 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 1 day ago | Updated 1 day 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 1 day ago | Updated 1 hour 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 15 days ago

Sr. Biostatistician needed for Remote Job longterm Contract!!!

Nam Info Inc

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Remote or US

Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role : Sr. Biostatistician Location:Remote Duration : 6+ months contract EST time zone- candidate need to work in EST time Skills: At least 8years of experience In Addition to the above Statistical Programming II experience Lead statistica
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Posted 4 days ago | Updated 1 day 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 13 days ago | Updated 8 hours ago