FDA Jobs

Refine Results
21 - 40 of 518 Jobs

Project Engineer

Jobot

•

Ashland, Ohio, USA

Full-time

Project Engineering - Global Company - Top Tier Compensation, Benefits and PTO This Jobot Job is hosted by: Phil Carlier Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $120,000 - $160,000 per year A bit about us: Our client is a global leader in the Food & Beverage industry. They've been in business for over a century and offer top tier compensation, benefits, PTO and upward mobility. Due to the necessity of their industry they are always
Posted 3 days ago | Updated 11 hours ago

Remote Care Technical Support Technician - Onsite

VIVA USA INC

•

Pleasanton, California, USA

Contract

Title: Remote Care Technical Support Technician - Onsite Mandatory skills: Clinical, lab, MS Word, Excel, Outlook, Customer service, Calls, Call Support, Remote Care Technical Support, business environment, customer issues, Medical, medical systems, medical environment, capital equipment systems, human capital utilization, R&D, Technical Services, patients, clinics, clinical applications, software support, field services, field service support, quality standards, quality system, quality actions
Easy Apply
Posted 4 days ago

Support Coordinator

Horizontal Talent

•

US

Contract

Join a dynamic team as a Support Coordinator, where you'll play a vital role in updating packaging graphics while collaborating with innovative professionals worldwide. This remote position offers the chance to contribute to impactful projects in a supportive and inclusive environment. Responsibilities Assist in updating and adapting packaging designs to align with new branding and legal requirements. Ensure consistency and accuracy in artwork and design content following packaging guidelines. M
Easy Apply
Posted 21 hours ago | Updated 16 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,
Easy Apply
Posted 4 days ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

•

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
Easy Apply
Posted 4 days ago | Updated 20 hours ago

Quality Management Systems (QMS) and Cybersecurity Compliance Specialist

Dew Software

•

Massachusetts, USA

Contract, Third Party

Job Description: Seeking a skilled Quality Management Systems (QMS) and Cybersecurity Compliance Specialist to lead the integration and upgrade of our QMS, assist in internal cybersecurity audits, and provide regulatory submission support (FDA, EU) at our Boston site. The ideal candidate will bring a comprehensive understanding of quality management processes, document control, and corrective and preventive actions (CAPA), with experience supporting regulatory compliance initiatives. Key Respon
Easy Apply
Posted 60+ days ago | Updated 6 hours ago

Experienced Data Scientist

Johnson & Johnson

•

Danvers, Massachusetts, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 18 days ago | Updated 2 hours 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
Easy Apply
Posted 60+ days ago | Updated 9 hours ago

CAPA Quality Engineer (2 Openings)(ONSITE)(No C2C/H1B)

NetSource, Inc.

•

Cedar Creek, Texas, USA

Contract

(No C2C/H1B) Please note that this is a 12 to 18-month contract position. Job Posting Qualifications Bachelor s or Master s Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc., is preferred.4+ years of experience in a similar position within the Life science/Pharma industry.Medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is re
Easy Apply
Posted 19 hours ago | Updated 15 hours ago

Onsite Contract: eDiscovery CyberSecurity Onsite Consultant ( Digital Forensics, Cybersecurity Investigations, EDRM )

Seine LLC

•

Waukesha, Wisconsin, USA

Contract

Title: Onsite Contract: eDiscovery Cyber Security Onsite Consultant (Digital Forensics, Cybersecurity Investigations, EDRM ) Duration: 6-12 months 100% onsite in Waukesha, WI Industry: Medical Device/Healthcare Strong Microsoft Product expertise: OS365,Sharepoint, Exchange, Active Directory, Windows Endpoints Technical Tools: eDiscovery ( Relativity, Nuix, EnCase) Compliance: HIPAA, GDPR Regulatory: FDA, HIPAA, GDPR The eDiscovery (Cybersecurity) Specialist will be responsible for supporting l
Easy Apply
Posted 5 days ago | Updated 2 days ago

Windchill Consultant

Teknikoz

•

Sunnyvale, California, USA

Contract, Third Party

PTC Arena Consultant Job Description:We are seeking a skilled and proactive PTC Arena Consultant with a minimum of 3 years of hands-on experience in Arena PLM/QMS systems. The ideal candidate will play a key role in supporting, configuring, and enhancing Arena PLM to meet our product development and compliance needs. You will collaborate with cross-functional teams including Engineering, Quality, Regulatory, and Manufacturing to ensure smooth implementation and ongoing optimization of Arena s
Easy Apply
Posted 11 days 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
Easy Apply
Posted 60+ days ago | Updated 9 hours 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 11 days ago | Updated 6 days ago

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

•

Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato
Easy Apply
Posted 4 days ago | Updated 4 days 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
Easy Apply
Posted 21 hours ago

Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.
Posted 8 days ago | Updated 2 hours ago

R&D Engineer with Medical Device

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

Job Description: We are seeking a motivated and innovative R&D Engineer to support the design, development, and testing of medical devices in compliance with FDA and ISO standards. The ideal candidate will work closely with cross-functional teams to bring new products from concept to commercialization. Responsibilities: Design and develop medical devices and components from concept to production. Create design inputs, outputs, risk analysis, and test protocols. Perform design verification and
Posted 5 days ago | Updated 2 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
Easy Apply
Posted 21 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Roles & Responsibilities: Software quality assurance or software validation. Preferably within the medical device industry. Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304. Experience in non-product software validation. Includes tools for development, testing, maintenance. Deep understanding of quality standards and regulatory requirements: FDA 21 CFR Part 820. ISO 13485. IEC 62304. Software quality assurance. Software validation. Non-product software tools (for testing
Posted 2 days ago | Updated 2 hours ago

ATE Software Validation Engineer Medical Devices

Sureminds Solutions

•

Skaneateles Falls, New York, USA

Third Party, Contract

Job Title: ATE Software Validation Engineer Medical Devices Location: Skaneateles Falls, NY (Onsite) Duration : Long-Term Interview Mode : Video Job Description : Automatic Test Equipment (ATE) Software Validation Engineer Lead software validation efforts for ATE systems used in testing infusion pumps, patient monitors, or diagnostic devices.Develop validation protocols, test plans, scripts, and reports in alignment with FDA 21 CFR Part 820, Part 11, and ISO 13485. Key Responsibilities: Lead sof
Easy Apply
Posted 3 days ago