Fda jobs in massachusetts

FDA Medical Validation Engineer - Remote

Remote

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Today

Job Title: FDA Medical Validation Engineer Remote Contract Position Description The validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s Health policies and procedures, and industry standards. This individual will assist the company to develop and im

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Contract

Depends on Experience

VP of IT

Hybrid in Watertown, Massachusetts

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3d ago

Title: VP of ITLocation: Watertown, MA (Hybrid: 3-4 days/week onsite)Duration: Direct HirePosition Summary: We need a technology strategy that keeps pace with growing complexity across regulatory, scientific, and business needs. As our first VP, IT, you'll build and own that strategy, getting systems and infrastructure phase-appropriate before scale becomes a bottleneck. This is a highly cross-functional, hands-on leadership role, with real ownership to build the function from the ground up. Ke

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Full-time

Depends on Experience

GRC Analyst

Remote

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Today

This is a 3 Month Contract to Hire Opportunity. This position is 100% Remote. This is an outstanding opportunity for a Sr. GRC Analyst to participate in large global GRC initiatives that literally save lives. We are a leading global biotech company committed to improving human health through scientific innovation. With a 50+ year legacy of excellence, our publicly traded organization employs over 7,000 global team members, holds 750+ product patents, and generates $6.6 billion in revenue with $1

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Contract

$60 - $70

Senior Design Quality Engineer

Andover, Massachusetts

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Today

Role name: Senior Design Quality Engineer Work Location: Andover, MA Start date: Immediate availability. Interview Mode: Phone/Video Type: Contract (C2C/W2) Senior Design Quality Engineer Location: Andover, MA OR Remote Qualifications: Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline Advanced degree (Master s) in Engineering, Quality, or Regulatory Affairs preferred Re

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

Regulatory Affairs Specialist Small Molecule

Remote

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2d ago

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Bioinformatics Product Owner

Remote

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24d ago

Hello, We are seeking an experienced Product Owner to drive the development of a cutting-edge test designed to identify clinically actionable mutations in patients with solid tumors. This role is crucial in ensuring seamless coordination across software development, bioinformatics, clinical genomics, and regulatory teams to deliver high-quality, compliant, and innovative software solutions for precision oncology. Pay rate : $42 on W2 OR $48 on C2C Location : Remote Key Responsibilities: Define a

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Contract

40 - 45

Validation Engineer

Boston, Massachusetts

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15d ago

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

Pharmacovigilance (PV) Specialist / Drug Safety Case Processing Specialist/Clinical Trial Consultant

Remote

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9d ago

Job Description: Responsible for processing and quality checking (QC) of clinical trial and post-marketing Individual Case Safety Reports (ICSRs). Key responsibilities include case intake, triage, data entry, MedDRA coding, narrative writing, follow-up queries, case reconciliation, and ensuring timely regulatory reporting in compliance with global pharmacovigilance regulations. Required Skills: Bachelors degree in Science or a healthcare-related field. 4+ years of experience in Pharmacovigilance

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Contract

Embedded Verification and Validation (V&V) Engineer

Waltham, Massachusetts

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Yesterday

Experience: 10+ years of commercial software test engineering experience, with a proven track record in a medical device or scientific instrument environment.Deep Embedded Expertise: Extensive, hands-on experience testing deeply embedded systems where software directly controls physical hardware components.Regulatory Mastery: Proven commercial experience testing and shipping medical devices under ISO 13485, along with familiarity with current FDA cybersecurity requirements.Testing Methodologies:

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Full-time

$130,000 - $140,000

Director - Food & Agri. Business Transformation

Remote

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17d ago

Director - Food & Agri. Business Transformation Mode - Remote (MST) Job Type: Full Time Experience Requirement: 15-20 years: Recent experience must be with a leading consulting firm serving the Food & Agribusiness sector. Preferred employers: Big 4 Consulting or equivalent.Across the overall career span, candidate must possess ~5 years of Industry domain experience in Food & Agribusiness. The ideal candidate should have deep, demonstrable expertise across one or more Food & Agri sub-sectors Ag

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Full-time

Depends on Experience

Validation Engineer

Remote

•

Today

Validation Engineer Remote Long Term Contract validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s Health policies and procedures, and industry standards. This individual will assist the company to develop and implement operating procedures associate

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Contract, Third Party

Depends on Experience

Trade Compliance Analyst

Remote or New York, New York

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Today

Title: - Trade Compliance Analyst Location: New York, NY, 10001 Duration: 12 months (possible for extensions) Fully Remote Position Job Description: Trade Compliance Analyst Position Summary: The Trade Compliance Analyst is responsible for supporting U.S. import compliance activities and ensuring adherence to U.S. Customs regulations and Partner Government Agency (PGA) requirements. This role partners with customs brokers, government agencies, logistics providers, and internal stakeholders to

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Third Party, Contract

$Market

Product Quality Engineer 2

Marlborough, Massachusetts

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Today

Job Description Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Product Quality Engineer 2 to provide engineering support for on-market medical devices. In this role, you'll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you'll drive process improvements, assess risks, and de

Full-time

USD 78,000.00 - 122,100.00 per year

CSV Validation Engineer

Boston, Massachusetts

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15d ago

Job Summary We are seeking a Medical Device Quality / CSV Validation Engineer to support quality system compliance, CAPA remediation, spreadsheet validation, and computer system/software validation activities within a regulated medical device environment. The ideal candidate will have strong knowledge of FDA 21 CFR Part 820, ISO 13485, risk Roles & Responsibilities Review spreadsheet inventories and assess validation requirements based on applicable procedures, risk, and quality standards. Perfo

Full-time

Oracle EBS/ ERP Federal Financials Functional Consultant

Remote

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2d ago

Position: Sr Oracle EBS/ ERP Federal Financials Functional Consultant Location: Remote for DMV Location only Duration: Longterm VISA: No Constraints Rate: $ Open on W2/C2C No of Positions: Client: SAS Global Services LLC / FDA We work with ( H1b transfers and any EAD) Mandatory Skills: Must have 10+ years of Oracle ERP experience and strong hands on with R12Should be eligible to get public trust clearance and must have worked in the US for the last 5 years.Experience with PRISM, IPP, Travel int

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Third Party, Contract

Depends on Experience

Clinical Engineer II

Boston, Massachusetts

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Today

POSITION SUMMARY: Under general direction performs a variety of very skilled repair and maintenance activities on sophisticated anesthesia, patient monitoring and other patient related equipment located in critical care and surgery. Performs in-depth troubleshooting and diagnostics on sophisticated technology. Assists in the initiation and completion of clinical evaluations. Assists in the compilation of a sensible capital acquisition plan for the Medical Center's operating rooms. Assists in th

Full-time

USD 42.87 - 55.46 per hour

Mechanical Engineer

Foxborough, Massachusetts

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Today

Dear Candidate, My name is Manisha Singh and I am a recruiter at Stellent IT LLC. I am reaching out to you on an exciting job opportunity with one of our clients. Should you be interested, please send me a copy of your resume in word format along with your LinkedIn URL. We have a Mechanical Engineer role that is full time if you are interested. Need American born s no job shoppers. Candidates need to have a LinkedIn Profile as well. Vertical is Medical Device Mechanical Engineer - Medical Dev

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Full-time

Senior Principal GMP Compliance Auditor

Cambridge, Massachusetts

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Today

Location: Cambridge, MA Salary: $95.00 USD Hourly - $135.00 USD Hourly Description: Title: Principal GMP Compliance Auditor Type: 10+ Month Contract Location: Remote with travel domestic and international Seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical manufacturing sites, laboratories, suppliers, CMOs, and quality systems. This role serves as a subject matter expert in global regulatory compliance, inspection readiness, and quality sys

Contract

Compensation information provided in the description

Senior Engineer, Quality Engineering

Wilmington, Massachusetts

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Today

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and software technologies into solutions that combat climate change, reliably connect humans and the world, and help drive advancements in automation and robotics, mobility, healthcare, energy and data centers. With revenue of more than $11 billion in FY25, ADI ensures today's inno

Full-time

USD 95,600.00 - 131,450.00 per year

Computer Vision Engineer

Remote

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2d ago

Role: Computer Vision EngineerLocation: Remote with travel required 50%Duration: 6months with possible extensionRole OverviewWe are seeking a Computer Vision Engineer to own the development and integration of real-time automated visual inspection systems for our pharmaceutical packaging lines. In this role, you will design and deploy edge-based vision models that interface with high-speed cameras and IoT hardware to detect packaging defects, verify serialization, and ensure 100% quality complian

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Contract

Depends on Experience

Fda jobs in Massachusetts, USA