fda Jobs in denver, co

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Product Security EngineerJob Title - Product Security Engineer

Tekfortune Inc.Company Name - Tekfortune Inc.

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Remote

Contract, Third Party

Note- Cybersecurity experience in medical device / Healthcare domain is mandatory Apart from JD, Look for Deliver documentation for pre-market product development activities including security plans, architecturediagrams, data fl ow diagrams, threat models, security requirements, Design for Security, SBOM, and risk management documentation. Drive and monitor and post-market vulnerability management activities, with adherence to strict timelines. Support compliance certification activities, such

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Senior Technical Analyst with Pharmaceutical domain onlyJob Title - Senior Technical Analyst with Pharmaceutical domain only

Byteware Inc.Company Name - Byteware Inc.

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Remote or West Point, Pennsylvania, USA

Contract, Third Party

Sr Technical Analyst with pharmaceutical DomainBranchburg or West Point PA (Hybrid)Pharma Domain is must required in Recent experience.Responsibilities:Data Analysis and Reporting:Collect, analyze, and interpret technical data related to pharmaceutical processes, product development, and clinical trials.Generate detailed reports and visualizations to support decision-making and present findings to stakeholders.System and Software Management:Manage and maintain technical systems and software appl

LIMS and QC Applications ConsultantJob Title - LIMS and QC Applications Consultant

Expedite Technology SolutionsCompany Name - Expedite Technology Solutions

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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

Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)Job Title - Medical Devices Software Program Manager (REMOTE/WEST COAST CANDIDATES)

Amerit ConsultingCompany Name - Amerit Consulting

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Remote

Contract

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Software Program Manager NOTE: THIS IS REMOTE ROLE & ONLY W2 CANDIDATES (NO C2C/1099) Candidate must be authorized to work in USA without requiring sponsorship Position: Medical Devices Software Program Manager(Job Id - # CFNJP00051124) Location: San Diego CA 92130 (Remote) Duration: 6 months + Contract to

Business Quality Assurance (BQA)Job Title - Business Quality Assurance (BQA)

Activesoft, Inc.Company Name - Activesoft, Inc.

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Remote

Contract

Mandatory Skills & Qualifications: Strong knowledge in GMP, cGMP, and regulatory standards:21 CFR Part 1121 CFR Part 21021 CFR Part 211ICH Q7Experience facing FDA audits at pharmaceutical manufacturing sitesHands-on experience with manufacturing processes, CAPAs, deviations, etc.Lead Auditor or any other compliance certifications (preferred)

Product Security EngineerJob Title - Product Security Engineer

SignitivesCompany Name - Signitives

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Remote

Contract

Title: Product Security Engineer Location: Danvers, MA (Remote candidates considered) Domain: Medical Device / Healthcare Job Summary:A leading innovator in medical devices, is seeking for experienced Product Security Engineers to join our growing team. This role is critical for ensuring the security of our medical products throughout their lifecycle from pre-market development to post-market vulnerability management. Candidates must have prior cybersecurity experience in the medical device or h

Senior EM Navigation EngineerJob Title - Senior EM Navigation Engineer

Recruitment.aiCompany Name - Recruitment.ai

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Denver, Colorado, USA

Full-time

We are seeking experienced Senior EM Navigation Engineers to join our team in Colorado. The ideal candidates will have a strong background in electromagnetic (EM) navigation systems and proven experience working within the medical device industry. Key Responsibilities: Design, develop, and optimize EM navigation systems for medical device applicationsCollaborate with cross-functional teams (hardware, software, clinical) to ensure accurate and reliable system performanceContribute to system integ

Senior Supplier Quality EngineerJob Title - Senior Supplier Quality Engineer

JobotCompany Name - Jobot

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Aurora, Colorado, USA

Full-time

Full-Time & Direct Hire Senior Supplier Quality Engineer needed for Global Health-Tech Leader! This Jobot Job is hosted by: James Thai Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $90,000 - $120,000 per year A bit about us: Based in Colorado Springs, CO, we are reimagining healthcare through breakthrough technologies and human-centered design. Our company is a global leader in health innovation, creating smart systems that improve lives

SDET Data Quality EngineerJob Title - SDET Data Quality Engineer

Judge Group, Inc.Company Name - Judge Group, Inc.

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Denver, Colorado, USA

Full-time

Location: Denver, CO Salary: $65.00 USD Hourly - $75.00 USD Hourly Description: About the job Join a global medical-device & cell-therapy organization as a Senior SDET / Data-Quality Engineer. You'll automate data-quality pipelines on our Azure/Databricks lakehouse to ensure regulatory-grade, analytics-ready datasets for upcoming post-market analytics releases. Responsibilities Design, develop, and maintain automated data-validation frameworks for batch & streaming pipelines in Databricks.

Product Security Engineer-(Healthcare domain exp is mandatory)Job Title - Product Security Engineer-(Healthcare domain exp is mandatory)

ST Global LLCCompany Name - ST Global LLC

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Remote

Full-time, Third Party

Product Security Engineer-(Healthcare domain exp is mandatory) Remote is OK Here is an update and questionnaire attached. Please share candidates accordingly Software development Experience is mustCandidate should have development experience in medical devices and Cybersecurity activities end-to-end for medical devicesCandidate should have hands on experience in security risk management for medical devices including threat modeling, security risk assessment, risk ratings etc.Candidate should hav

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

SAP Manufacturing/Supply Chain Consultant :: RemoteJob Title - SAP Manufacturing/Supply Chain Consultant :: Remote

Bright SolCompany Name - Bright Sol

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Remote

Contract

Job Description:We are seeking a highly skilled SAP Manufacturing/Supply Chain Consultant to join our team in Sunnyvale, CA. The ideal candidate will bring deep expertise in SAP PP, MM, and APO/IBP modules, with proven experience in manufacturing and supply chain process optimization, preferably within the medical device or high-tech industry. You will play a key role in designing, configuring, and implementing SAP solutions to support production planning, shop floor operations, inventory manage

Regulatory affairs - CMC ManagerJob Title - Regulatory affairs - CMC Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Contract

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su

Sr. Project Manager with PLM and Medtronics ExpJob Title - Sr. Project Manager with PLM and Medtronics Exp

Spar Information SystemsCompany Name - Spar Information Systems

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Full-time, Part-time, Third Party, Contract

Hello; Senior Project Manager with Work Experience in Medtronics, PLM and Regulatory Experience Job location:- Remote Long Term Note from the client:- Candidate should worked with Medtronics Previously and has PLM and Regulatory Experience Level Skill Core Concepts Expert Product Lifecycle Management (PLM) Systems Windchill, Teamcenter, Change Management, Product Data Management, Configuration Control Expert Medtech Regulatory Compliance Knowledge FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FU

Appian Developer - Remote!Job Title - Appian Developer - Remote!

General DynamicsCompany Name - General Dynamics

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Remote

Full-time

Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 4 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on a

Human Factors LeadJob Title - Human Factors Lead

Apidel TechnologiesCompany Name - Apidel Technologies

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Remote

Contract

Human Factors Lead (Fully remote job) Job Description: Reporting to the Medical affairs (MA), this role defines work roles and oversees human factors, user experience, and preclinical activities for direct reports and extended core-team team members. Ensures MA function has necessary skills and resources to execute on develop projects as part of business goals and associates are compliant in following procedures. The Senior Manager will lead a Human Factor reviews and all related activity inclu

UX Designer / UX WriterJob Title - UX Designer / UX Writer

Beacon Systems, IncCompany Name - Beacon Systems, Inc

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Remote

Contract

Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. We are looking for a UX Designer / UX Writer - Remote- Orlando, FLRequest you to make sure your updated Resume highlight

Product OwnerJob Title - Product Owner

Tandym TechCompany Name - Tandym Tech

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Remote

Contract

A leading organization in Washington, D.C., is looking to hire an experienced Product Owner for a Remote, contract role. As a Product Owner, you'll collaborate across technical and business teams to drive product strategy, streamline backlogs, and deliver top-tier functionality that supports organizational growth and innovation. This is an exciting opportunity for a strategic and innovative thinker who thrives in Agile environments and can transform business goals into actionable roadmaps. Abou

MES ConsultantJob Title - MES Consultant

BOTG LLCCompany Name - BOTG LLC

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Remote

Full-time

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact