FDA Jobs in New York, NY

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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 hour ago

Compliance Head, U.S. FDA

Sanofi

•

Morristown, New Jersey, USA

Full-time

Job DescriptionJob Title: Compliance Head, U.S. FDA Location: Framingham, MA (Primary); Morristown, NJ, Swiftwater, PA About the Job We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Foster best-in-class performance by leveraging data, techno
Posted 34 days ago | Updated 6 hours ago

FSQA - Food Safety and Quality Assurance Manager

Agile Global Solutions, Inc

•

Linden, New Jersey, USA

Full-time

Position Overview: The FSQA Leader will play a key role in advancing the facilitys food safety and quality programs, ensuring alignment with regulatory standards (FDA, USDA, HACCP, FSMA), customer expectations, and internal best practices. This position offers an exciting opportunity to contribute to a dynamic, forward-thinking culture focused on quality, innovation, and operational excellence. Key Responsibilities: Lead, enhance, and support food safety and quality assurance programs, including
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Posted 3 days ago | Updated 3 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 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 1 day 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

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 5 days ago | Updated moments ago

Business developer Manager- Medtech/Healthcare

Showman Staffing

•

Remote

Full-time

Job Title: Sr.Business Developer Manager Experience: 6+yrs Location: Remote-Travel required-100% client location-Candidates should be in USA Job: Permanent Full Time Requirement Role Overview We are seeking a passionate and driven Sales professional to accelerate our growth in the Healthcare and MedTech space one of the most rapidly evolving sectors today. You will work with a high performing team targeting innovative healthcare providers, MedTech firms, and digital health disruptors to bring c
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Posted 4 hours 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 5 days ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

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Remote

Contract, Third Party

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 5 days ago | Updated 3 hours ago

Regulatory Studio CMS Senior Manager

CBase Inc

•

Jersey City, New Jersey, USA

Full-time

Job Title: Regulatory Studio CMS Senior ManagerLocation: 100% Onsite New Brunswick (preferred) or Lawrenceville, NJDuration: 11 Months Contract Top Required Skills / Must-Haves: 2 3 years of Small Molecule Drug Development experienceHands-on experience with Veeva System (Documentum)Strong verbal and written communication skills5+ years in the pharmaceutical industry3+ years CMC regulatory experience (Sterile Injectable experience preferred) The highlights are as below: - Experience with Veeva
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Posted 1 day ago

Clinical SAS Programmer

Katalyst Healthcares and Lifesciences

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Newark, New Jersey, USA

Full-time

Responsibilities: Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s). Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets. Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements. Provides input in the design and development of case report forms and clinical databases.
Posted 2 days ago | Updated 8 hours ago

MES Engineer with Werum PAS-X

PDDN Inc

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New York, New York, USA

Contract, Third Party

Role: MES Engineer Location: New York, NY / Raritan, NJ Interview: Phone/Skype Job Type: Contract JOB DESCRIPTION: PAS-X Senior Engineer Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes. Key Responsibilities: Development\Modification\Upgrade\Enhancement of MBR s and GMBR
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Posted 3 days ago | Updated 1 hour ago

Adobe Campaign Technical Lead/Architect

Codinix Technologies Inc.

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New York, New York, USA

Contract

Job Description We are seeking an experienced and strategic Adobe Campaign Technical Lead / Architect to lead our marketing technology initiatives. The ideal candidate will possess a deep understanding of Adobe Campaign platforms and related Adobe Experience Cloud tools, with a strong track record of designing and implementing scalable, data-driven marketing solutions. This role requires both hands-on technical skills and leadership capabilities to drive innovation and campaign effectiveness. Wo
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Posted 45 days ago | Updated 19 days ago

Mechanical & Biomedical Engineer

Katalyst Healthcares and Lifesciences

•

Belleville, New Jersey, USA

Full-time

Responsibilities: Lead/contribute to device development, design controls and risk management strategy for the assigned projects. Lead the implementation and/or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers. Proactively resolve project
Posted 60+ days ago | Updated 8 hours ago

Regulatory Studio CMS Senior Manager

Sureminds Solutions

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New Brunswick, New Jersey, USA

Contract, Third Party

Job Title: Regulatory Studio CMS Senior Manager Location: New Brunswick, NJ/ Lawrenceville, NJ (Onsite) Duration : 11 Months Interview Mode : Video Job Description : 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 higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory exper
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Posted 1 day ago

Regulatory Studio CMS Senior Manager

Digitive LLC

•

New Brunswick, New Jersey, USA

Contract, Third Party

Job Title: Regulatory Studio CMS Senior Manager Location: New Brunswick (preferred), Lawrenceville (Hybrid) Experience: 10 years 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 higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience
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Posted 1 day ago

Regulatory Studio CMS Senior Manager

Digitive LLC

•

New Brunswick, New Jersey, USA

Contract

Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville , NJ Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Term:Contract Pay Rate - $47/hr on w2 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 h
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Posted 1 day ago | Updated 1 day ago

Automation Control Engineer

Katalyst Healthcares and Lifesciences

•

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa
Posted 60+ days ago | Updated 8 hours ago

Sr. Mechanical Engineer

Katalyst Healthcares and Lifesciences

•

Rahway, New Jersey, USA

Full-time

Responsibilities: Apply subject matter expertise in mechanical design, analysis, and system development. Conceive and develop solutions to complex analytical, pneumatic, mechanical, and electrical design challenges. Establish design objectives and contribute to writing specifications and comprehensive engineering reports. Participate in the review and development of detailed product specifications. Conduct conceptual and detailed design studies using MCAD, Solidworks, and other tools. Coll
Posted 55 days ago | Updated 8 hours ago