fda Jobs in boston, ma

41 - 60 of 95 Jobs

Senior Process EngineerJob Title - Senior Process Engineer

Johnson & JohnsonCompany Name - Johnson & Johnson

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Raynham, 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

SAP GTS Business Function Implementation Lead (Remote Work)Job Title - SAP GTS Business Function Implementation Lead (Remote Work)

Source Code Technologies LLCCompany Name - Source Code Technologies LLC

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Remote

Contract, Third Party

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on

R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA)Job Title - R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA)

Philips North AmericaCompany Name - Philips North America

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Cambridge, Massachusetts, USA

Full-time

Job Title R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA) Job Description R&D Application Software Engineer - C++ & Python for Medical Device (Cambridge, MA) Join the Breakthrough Innovation Teams (BRITE) at Philips to build next-gen surgical robots and bring better care for more people. BRITE is the embodiment of Philips' approach to driving breakthrough innovation by accelerating innovation to nurture nascent projects from early innovation stage to full a

Senior Automation EngineerJob Title - Senior Automation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: As a Senior Automation Engineer, you will work in a hybrid position and be part of the Automation engineering group

Principal Regulatory Consultant Dietary SupplementsJob Title - Principal Regulatory Consultant Dietary Supplements

Apptad IncCompany Name - Apptad Inc

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New Jersey, USA

Third Party, Contract

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

Supplier Engineer IIJob Title - Supplier Engineer II

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Danvers, Massachusetts, USA

Full-time

Document Management Specilist (W2 Only - 100% Remote)Job Title - Document Management Specilist (W2 Only - 100% Remote)

Performix Business Services, LLCCompany Name - Performix Business Services, LLC

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Remote or Rochester, Minnesota, USA

Contract

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist

Sr. Software Quality EngineerJob Title - Sr. Software Quality Engineer

Fresenius Medical CareCompany Name - Fresenius Medical Care

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Remote or Lawrence, Massachusetts, USA

Full-time

Position Location Details - Upon agreement between you and your supervisor, you are entitled to a flexible arrangement where you will be able to split your time between working from the office and working remotely. PURPOSE AND SCOPE Act as a Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and

Computer System Validation (CSV) EngineerJob Title - Computer System Validation (CSV) Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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. Author 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

CQV EngineerJob Title - CQV Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

Remote QA Manager with Healthcare Payer and Claims expJob Title - Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)Company Name - Infinite Computer Solutions (ICS)

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Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye

Sr. Principal StatisticsJob Title - Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLCCompany Name - PARAKEET WORLD SOLUTIONS LLC

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Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol

Automation EngineerJob Title - Automation Engineer

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: As an Automation Engineer I role, you will work in a hybrid position and is part of the Automation engineering group

Clinical Data managerJob Title - Clinical Data manager

Intone Networks Inc.Company Name - Intone Networks Inc.

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Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T

Product Security EngineerJob Title - Product Security Engineer

Apex SystemsCompany Name - Apex Systems

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Danvers, Massachusetts, USA

Full-time

Job#: 2061518 Job Description: Position: Product Security Engineer Location: Remote (supporting EST hours) Primary Duties And Responsibilities Partner with engineering teams (cloud, console, pump, etc.) to drive successful adherence to the product security program.Create, update, and mature product security processes.Deliver documentation for pre-market development activities including security plans, architecture and data flow diagrams, threat models, requirements, SBOM, and risk documentation.

Senior Software EngineerJob Title - Senior Software Engineer

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Marlborough, Massachusetts, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Senior Software E

Job Title: Product Manager Healthcare RemoteJob Title - Job Title: Product Manager Healthcare Remote

Think Big Solutions, IncCompany Name - Think Big Solutions, Inc

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Remote

Contract

Job Title: Product Manager Healthcare Location: [City, State or Remote] Job Type: [Full-Time / Part-Time / Contract] Job Summary: We are seeking an experienced and strategic Product Manager with a background in healthcare to lead the development and execution of products that improve patient outcomes, provider workflows, or payer efficiency. The ideal candidate will have a strong understanding of healthcare systems, regulations (e.g., HIPAA, HL7, FHIR), and the complexities of healthcare deliver

Sales headJob Title - Sales head

Showman StaffingCompany Name - Showman Staffing

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Remote

Full-time

Job Title: Sales Head Experience: 6+yrs Location: Remote-Travel required(100% travel) 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 cutting-edge technology solutions to life. You will repr

Clinical Data Coder (Remote, Part-Time)Job Title - Clinical Data Coder (Remote, Part-Time)

Real Soft, Inc / Diversity DirectCompany Name - Real Soft, Inc / Diversity Direct

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Remote

Part-time

Job Overview We are seeking a detail-oriented and technically proficient Clinical Data Coder to support the accurate and timely coding of medical and medication terms within our electronic data capture (EDC) systems, primarily Rave Coder. This part-time remote role plays a vital part in ensuring data integrity and regulatory compliance across oncology clinical trials. Job Duties and Responsibilities Perform ongoing medical and medication coding using Rave Coder in alignment with MedDRA and WHO D

Senior Software Test Engineer - ElectrophysiologyJob Title - Senior Software Test Engineer - Electrophysiology

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Waltham, Massachusetts, USA

Full-time

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your