FDA Jobs

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Systems EngineerJob Title - Systems Engineer

MindlanceCompany Name - Mindlance

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Remote

Contract

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

Proposal Writer / Proposal Development SpecialistJob Title - Proposal Writer / Proposal Development Specialist

ExpediteInfoTech, Inc.Company Name - ExpediteInfoTech, Inc.

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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

Consultant, XRPD for Solid Oral dosage, GIJob Title - Consultant, XRPD for Solid Oral dosage, GI

Eliassen GroupCompany Name - Eliassen Group

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Anywhere, US

Contract

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str

Medical Device Validation/Quality Engineer (ONSITE- No H1B/C2C)Job Title - Medical Device Validation/Quality Engineer (ONSITE- No H1B/C2C)

NetSource, Inc.Company Name - NetSource, Inc.

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Rochester, New York, USA

Contract

Please submit your resume only if you have a Bachelor Degree in Medical Device. The client may consider a degree in biology, chemistry, or a clinical field. Please don't send technical resumes; this is not a technical role. Technical resumes will be rejected. No H1B/C2C Please note that this is a 1-year position. Prefer candidates with a BS in Medical Technology. Candidates with this background are better suited for the senior-level position. Strong understanding of the lab environment and day

cGMP Blood Bank Technician (ONSITE)(1st Shift or Night Shift)Job Title - cGMP Blood Bank Technician (ONSITE)(1st Shift or Night Shift)

NetSource, Inc.Company Name - NetSource, Inc.

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Pompano Beach, Florida, USA

Contract

Please note that this is a 1-year contract. Only local candidates need to apply. The target shift for this role will be either first shift or night shift (target time 12 AM to 8:30 AM) Qualifications: The Serologist I will be responsible for performing quality control testing according to established procedures and timelines.Weekends and OT is occasionally requiredMust be able to lift a maximum of 35 poundsDocuments results clearly and accurately. Interprets results by complying with appropriate

Senior Embedded EngineerJob Title - Senior Embedded Engineer

Elite TechnicalCompany Name - Elite Technical

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Boca Raton, Florida, USA

Full-time

Elite Technical's client, a start-up biotech company based in Boca Raton FL that specializes in developing cutting-edge devices that save lives and improve the quality of life for patients with all cancer diseases and stages, is seeking a Senior Embedded Engineer! The selected candidate will join and lead their medical device hardware development team. This role requires being present 5x per week at their office in Boca Raton FL working with their global R&D and clinical research teams. A reloca

Embedded Test Engineer (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools)Job Title - Embedded Test Engineer (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools)

Cigniti Technologies IncCompany Name - Cigniti Technologies Inc

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Acton, Massachusetts, USA

Full-time

Job details: Job Role: Embedded tester (Bluetooth Protocol tools Sodera, nRF sniffers, Power Analyzer tools) Location: Acton, MA Must Have Skill sets:experience in Embedded device /Hardware Testing knowledge Ability to perform whitebox testing, unit testing Hands on experience in mobile app or mobile device testing. Hands on experience in Python/Appium is added advantage. Experience on working, Test Hardware and boards Perform end-to-end functional testing and validation for the application

Technical Proposal Solutions ArchitectJob Title - Technical Proposal Solutions Architect

ExpediteInfoTech, Inc.Company Name - ExpediteInfoTech, Inc.

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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

Technical Fellow R&D: Capital DevicesJob Title - Technical Fellow R&D: Capital Devices

Avanos MedicalCompany Name - Avanos Medical

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Alpharetta, Georgia, USA

Full-time

Requisition ID:6404 Job Title:Technical Fellow R&D: Capital Devices Job Country:United States (US) Here at Avanos Medical, we passionately believe in three things: Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, and the lives of people and communi

Sr Full Stack EngineerJob Title - Sr Full Stack Engineer

Pinnacle Software SolutionsCompany Name - Pinnacle Software Solutions

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Remote

Contract

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular

SAP Plant Maintenance ConsultantJob Title - SAP Plant Maintenance Consultant

IT Resonance Inc.Company Name - IT Resonance Inc.

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Remote

Third Party, Contract

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-

Sr. QA ManagerJob Title - Sr. QA Manager

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Chelmsford, Massachusetts, USA

Full-time

Piper Companies is seeking a Senior Quality Assurance Manager to lead quality assurance efforts for a medical device facility in Chelmsford, MA through a M-F Onsite work schedule. The Senior Quality Assurance Manager is pivotal in ensuring compliance with regulatory standards and driving continuous improvement initiatives. Responsibilities of the Senior Quality Assurance Manager include: Lead quality assurance for two products: balloon pump and balloon catheter. Develop and execute QA strategie

Validation-Verification EngineerJob Title - Validation-Verification Engineer

IrisLogic, IncCompany Name - IrisLogic, Inc

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Minneapolis, Minnesota, USA

Contract

Bachelor s degree in Electrical or Mechanical 1+ years of experience in electromechanical V&V testing (medical devices preferred).Experience with medical device standards (e.g., IEC 60601, ISO 13485, FDA guidelines) is a plus.Hands-on experience with lab equipment (oscilloscopes, power supplies, force gauges, etc.).Develop and execute test protocols, analyze results, and support cross-functional teamsKey role in ensuring the safety, reliability, and compliance of electromechanical medical device

Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)Job Title - Regulatory Affairs - Labeling Strategy, Senior Manager (Remote)

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Remote or Atlanta, Georgia, USA

Full-time

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of

Product Security Engineer (Medical devices)Job Title - Product Security Engineer (Medical devices)

Laiba Technologies LLCCompany Name - Laiba Technologies LLC

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Danvers, Massachusetts, USA

Third Party, Contract

Role: Product Security EngineerLocation: Danvers, MA-01923 [On-site] Security risk management techniquesRegulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR)Pre-market product development activitiesMedical devicesFDA 5+ years industry experience in Information Security. Working knowledge of regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR). Experience with security risk managem

Virology Deviation Management SpecialistJob Title - Virology Deviation Management Specialist

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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West Point, Pennsylvania, USA

Full-time

Piper Companies is looking for a Virology Deviation Management Specialist for a leading pharmaceutical manufacturer in West Point, PA. Responsibilities: Conduct microbiological testing within investigations to prove root causeRecommend corrective and preventive actions (CAPAs)Conduct deviation OOS investigations related to testing within pharmaceutical manufacturing Qualifications: 2+ years of experience within GMP/FDA regulated environmentFamiliarity with virology Strong background in pharm

Sr. Full Stack Engineer (Remote)Job Title - Sr. Full Stack Engineer (Remote)

Pinnacle Software SolutionsCompany Name - Pinnacle Software Solutions

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Remote

Contract

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod

Sr. Manager, Quality ControlJob Title - Sr. Manager, Quality Control

EDI Specialists, Inc.Company Name - EDI Specialists, Inc.

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Walnut, California, USA

Full-time

Position Summary This position will lead quality control operations, ensuring compliance with industry regulations and high product standards. Reporting to senior leadership, this role oversees Microbiology, Analytical Chemistry, Quality Control, Inspection, Quality Assurance, and Validation while collaborating cross-functionally to support production and distribution. Key Responsibilities Oversee QC teams and ensure lab operations align with regulatory and business goals. Maintain and improve

Medical WriterJob Title - Medical Writer

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Bethesda, Maryland, USA

Full-time

Piper Companies is seeking a Clinical Project Manager to join a contract research organization located in Bethesda, MD. Responsibilities of the Medical Writer include: Working with both private and public sectors regarding the submission of various documents (scientific or regulatory) Provide different results in regard to document searches and document summaries Manage meeting filings and other documents associated (meeting reports, proceedings, safety documents, data analysis. Etc.) Provid

Material HandlerJob Title - Material Handler

Cynet SystemsCompany Name - Cynet Systems

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Pleasanton, California, USA

Contract

Job Description: Pay Range: $18.50hr - $21.50hr List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. Perform Material Movements both physically and systematically GeneXX Work Orders from an ERP system Perform Work Order Receipts in ERP system Perform cycle counting as required Maintain a neat and safe work environment Assist in the coordination and flow of product through manufacturing and assembly when needed Work in a cross