FDA jobs in Massachusetts

Remote

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7d ago

POSITION TITLE:Information Technology Specialist - FDA LOCATION:Remote CLEARANCE:Must be able to obtain aHigh-RiskPublic Trust COMPANY OVERVIEW At APV,weremore than a technology company werea mission-driven powerhouse transforming organizations through advanced technology and human ingenuity. Ourexpertisespans AI/ML, data architecture, low-code/no-code development, AgileDevSecOps, and cloud services, delivering scalable and meaningful solutions. In our Emerging Technology Lab, innovation drive

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Contract

Depends on Experience

Senior Android Developer

Remote

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7d ago

HiAssociate, Greetingsfor theday, We have a position as aSenior Android Engineerrole forRemote.Please find the job description below for this position. Role:Senior Android Engineer Location: Remote Duration: 24 Months Note: Healthcare or Medical Device experience is mandatory. Key Responsibilities: Triage and debug field issues reported by users of our Android applications. Analyze crash reports, logs, and other diagnostic data to identify the root cause of issues. Develop understanding of ex

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Contract

Depends on Experience

Junior Validation Engineer with CSV / CQV

Cambridge, Massachusetts

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18d ago

Arthur Lawrence is looking for a Junior Validation Engineer with CSV / CQV one our clients in Cambridge MA. Please find the job description below and send us your updated resume if interested: Must-Have Skills: Experience performing validation and calibration activities for pharmaceutical manufacturing and sterile processing equipment in compliance with GMP and 21 CFR Part 11 requirements. Hands-on experience supporting Master Validation Plans (MVPs), SOPs, validation protocols, and Process Per

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Contract, Third Party

$30 - $39

SAP QM Architect

Remote

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27d ago

SAP QM ArchitectThe SAP Quality Management (QM) Architect leads the design, implementation, and optimization of SAP QM solutions in a regulated medical device manufacturing environment. The role requires deep expertise in QM processes, strong cross-module integration skills, and hands-on experience across implementations, rollouts, and upgrades. The architect ensures quality processes meet FDA/ISO standards and seamlessly integrate with manufacturing, supply chain, and compliance systems. Respon

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Contract

Depends on Experience

Regulatory Specialist

Remote

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2d ago

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

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Contract

Depends on Experience

Auditor

Remote or Chicago, Illinois

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Today

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Clinical Research Scientist III - (Director/Assoc. Director level)

Remote or Hybrid in Parsippany-Troy Hills, New Jersey

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10d ago

Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols. Participates in protocol review discussions concerning scientific and procedural aspects of study design. Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision. With supervision, contributes to the design and development of CRFs, Data Management Manuals and Da

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Third Party, Contract

$100 - $110

QA Test Engineer

Remote

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25d ago

Blu Omega is seeking a QA Test Engineer to support a federal program focused on data validation and workflow testing within the FDAs Regulated Product Submission (RPS) program. This role operates in a remote environment and is responsible for executing functional, integration, and data verification tests. The position requires experience supporting testing efforts in a mission-driven environment, with a focus on data accuracy, integrity, and consistency. Program Overview Program: FDA Regulated P

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Full-time

125,000 - 135,000

Quality Data Management Analyst

Burlington, Massachusetts

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Today

HonorVet Technologies is a Service Disable Veteran-Owned IT staffing firm, ISO 9001 and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn''t a tagline; it''s the way we work. We don''t forward resumes and hope for the best. We take the time to understand where a professional like you is headed and only reach out when we genuinely believe there''s a fit worth exploring. Job Title: Quality Data Mana

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Contract

$48.56 - $53.36

Manufacturing Technician I

Lawrence, Massachusetts

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2d ago

Client LocationCountry: United StatesState/Province: MassachusettsCity: LawrenceAddress: 360 Merrimack Street, Lawrence*LawrencePOSTAL CODE: 01843Duties: Execute consumables manufacturing processes according to established Standard Operating Procedures (SOPs) Maintain strict adherence to quality standards and efficiency metrics Operate in cleanroom environments following contamination control protocols Handle consumable materials with precision under guidance of Group Leaders or trai

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Contract, Third Party

$25 - $25

Clinical Information Specialist with Womens Health Clinical Practice (W2 ONLY)

Remote

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Today

Clinical Information Specialist / W2 ONLY / REMOTE / Contract Role About our Customer & Role: Our DIRECT customer, a global leader in Pharmaceutical industry is seeking an experienced Clinical Information Specialist with at least 5 years of experience, in Women s Health Clinical Practice. The Clinical Liaison acts as a liaison for healthcare providers, supporting the clinical use of implantable contraception for trained clinicians with Nexplanon. Education / Certificates: Licensed Advanced Pra

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Contract

Depends on Experience

OT Security Architect----Bedford, MA -- candidates can work for any Client office--Hybrid

Hybrid in Bedford, Massachusetts

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19d ago

OT Security Architect Bedford, MA -- candidates can work for any Client office Skills: OT--Hands on strong exp risk management pharmaceutical cyber Rockwell PL Ignition SCADA compliance with EU Cyber Resilience Act (CRA) IEC 62443/ISA99 ISA 95 GMP FDA 21 CFR Part 11 Certification--added advantage at least try for few IEC 62443 Cybersecurity Expert GICSP / CISSP Rockwell Automation Sirisha N Sr IT Analyst Humac Inc.

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Contract, Third Party

Depends on Experience

Process Engineer

Billerica, Massachusetts

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9d ago

Process Engineer IIWe are seeking an experienced Process Engineer II to support radiopharmaceutical manufacturing operations. In this role, you will provide technical support to automated manufacturing lines, troubleshoot process and equipment issues, lead deviation investigations and CAPAs, and support process validation, equipment qualification, and continuous improvement initiatives. You will work closely with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure safe, complia

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Contract

Depends on Experience

CMO Digital Liaison & Data Steward

Remote

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Today

Business Analyst / Digital Steward CMO Connections Role Overview We are seeking a technically grounded Business Analyst / Digital Steward to support digital connections with external Contract Manufacturing Organizations (CMOs). This person will help own the digital engagement with external manufacturing partners end to end from partner onboarding and tech transfer through commercialization and long-term sustainment of inline products. The role operates across a matrixed portfolio of strategic CM

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Contract

Depends on Experience

SAP Security Consultant - Remote

Remote

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4d ago

Title: SAP Security Consultant - Remote Mandatory skills: SAP GRC, AC/PC, SAP BTP Technologies, enterprise-wide system solutions, SAP Security Role Design, user administration, SAP security requirements, SOX, FDA validation, SAP authorization management, SHS compliance requirements, SAP Audit Management, SAP ECC, S/4 HANA, SAP HANA, SAP BI NetWeaver, Fiori, SAP RISE, SAP GTS, SAP NFP, SAP MES, SAP BI systems, supporting tools, Security Weaver, SHARP, SAP role management, SAP Identity Management,

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Contract

52 - 57

Drug Safety Specialist

Hybrid in Waltham, Massachusetts

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4d ago

We are seeking aDrug Safety Specialistwith35 years of pharmacovigilance experienceand a clinical background (RN, BSN, RPh, or PharmD). The ideal candidate will support end-to-end adverse event case processing for marketed and investigational products, ensuring compliance with FDA, ICH, and Google Cloud Platform regulations. Required Skills: 35 years of Drug Safety/Pharmacovigilance experienceClinical degree (RN, BSN, RPh, or PharmD)Experience with AE/SAE case processing and safety surveillanceKn

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Contract

Staff Compliance Manager / GxP

Cambridge, Massachusetts

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Today

A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks. Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have devel

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Full-time

$170000 - $190000

Validation Engineer

Boston, Massachusetts

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Today

Job Summary: We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred. Roles & Responsibilit

Full-time

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

Design Assurance Engineer / Medical Devices

Marlborough, Massachusetts

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Today

A leading global technology company is looking for a Design Assurance Engineer to join its team in Marlborough, MA. This is a great opportunity for an engineer with 3-5 years of medical device experience who wants to take on meaningful work across the full product development lifecycle. You'll help develop and improve Class II electro-mechanical medical devices while working closely with Design Engineering, Quality, Regulatory, and external testing teams. You'll have the opportunity to work on p

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Full-time

$74000 - $105000

FDA jobs in Massachusetts, USA