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Remote - Senior Project Manager with FDA and GxP experience - CH

Empower Professionals

Remote

Third Party, Contract

Role: Senior Project Manager location: Remote Duration: 12+ Month Level Skill Core Concepts Expert Product Lifecycle Management (PLM) Systems Windchill, Teamcenter, Change Management, Product Data Management, Configuration Control Expert Medtech Regulatory Compliance Knowledge FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FURLS, BUDI Expert Stakeholder Management and Influence Cross-functional influence, Stakeholder mapping, SME engagement, Interpersonal diplomacy Proficient Cross-OUs Regulatory Pro

Chemist

ITS Technologies, Inc.

Bowling Green, Ohio, USA

Full-time

Integrated Talent Strategies (ITS) is seeking a Chemist to work in the Perryburg, OH area. This is a direct hire position that offers a variety of great benefits, including health insurance, 401(k), and paid time off.Description Conducts research, formulation and experimentation for new product development and process improvement. Experience formulating coatings which may include floor, paint, or automotive at the bench. Product development experience working with marketing from concept through

Product Security Engineer

Laiba Technologies LLC

Danvers, Massachusetts, USA

Contract, Third Party

Role: Product Security EngineerNo. of Positions: 1Hiring Mode: Contract (TP)Location: Danvers, MA-01923 [On-site] Job Description: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 management techniques.Demonstrated organizational skills, attention to detail, the ability to handle multiple assignments simultaneously in a timely mann

Engineer II

Pyramid Consulting, Inc.

Round Lake, Illinois, USA

Contract

Immediate need for a talented Engineer II. This is a 11+months contract opportunity with long-term potential and is located in Round Lake, IL/Plymouth MN (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID:25-70235 Pay Range: $35 - $36/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan . Key Responsibilities: Lead and support small to medium sized projects with global cross-functional t

Regulatory Project/Program Manager (Product DNA ecosystem)

Tellus Solutions

Remote

Contract

Job Description:As a key team member, the Sr. Regulatory Project Manager-Product DNA brings a leadership opportunity to make an impact supporting the Healthcare Product DNA Program; a major transformational program that will create a connected thread of non-transactional product data to support the entire product lifecycle. This will specifically drive changes and interfaces within our overall eco-system (PLM, MES and ERP). This program is planned as a multi- year program that will have multiple

Regulatory affairs - CMC Manager

Sureminds Solutions

Remote

Full-time

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Electrical Safety Engineer

Innova Solutions, Inc

Lake Forest, California, USA

Full-time

An Innova Solutions Client is immediately hiring for a Electrical Safety Engineer Position type: Fulltime Location: Lake Forest, CA-Onsite As an Electrical Safety Engineer, you will need: Minimum Qualifications: Job description: 4+ years of total experience.Electrical Engineering (or similar) with experience in medical device safety compliance .Expert knowledge of IEC 60601-1 for medical electrical equipment.Familiar with FDA Approval process.Proven experience working cross-functionally with R&D

Product Security Engineer

Vankay Systems

Danvers, Massachusetts, USA

Contract

Role: Product Security Engineer Hiring Mode: Contract (TP) Location: Danvers, MA-01923 [On-site] Skills Matrix Skill Last Used Experience in Years/month Rating (10 points) 1 = newbie 10 = expert Hands on Exp. Yes/No Security risk management techniques Regulatory standards and compliance frameworks (e.g., NIST Cybersecurity Framework,ISO27001, SOC2, HIPAA, GDPR) Pre-market product development activities Medical devices FDA Job Description: 5+ years industry experience in Information Security.Wor

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

New Jersey, USA

Contract, Third Party

Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools_JIRA Primary Skill- Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology Jo Description: Strong experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems P

Urgent Opening- QA Validation Engineer - Cypress, CA

SunRay Enterprise Inc

Cypress, California, USA

Contract

Hello Professional, Hope you are doing well. This is Dharm from Sunray Corporation I found your resume suitable for one of the prime position with one of our client. Please find below the job description and let me know if you would be comfortable with Role : QA Validation EngineerLocation : Cypress, CADuration : 9+ Months Role OverviewExperience in Pharmaceutical Manufacturing, Biotechnology, and Medical device companies Performed Computer System Validation of cloud/server-based systemsInvol

IT&D Product Manager Manufacturing

Apex 2000

Evansville, Indiana, USA

Contract

IT&D Product Manager Manufacturing Location: Evansville, IN Duration: 9-12 Month Implementing Client: Infosys JD: Position Summary The Manufacturing OT/IT Manager will play a strategic leadership role in the development, integration, and support of Operational Technology (OT) and Information Technology (IT) systems across our manufacturing facilities. This role is critical in ensuring system interoperability, regulatory compliance (GMP, FDA), and the implementation of advanced technologies tha

LIMS and QC Applications Consultant

Expedite Technology Solutions

Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

JD Edwards Functional Analyst ? Full-Time (Hybrid)

iSphere

Houston, Texas, USA

Full-time

Job Title: Oracle JD Edwards Functional Analyst - Full-Time (Hybrid)Location: Houston, TX (Hybrid - 60% onsite, 40% remote) after onboard and supervisor approval. Job Type: Full-Time / Direct HireIndustry: Energy, Manufacturing, Distribution, Finance, ERP Systems About the Role:Our Houston-based client is seeking a skilled Oracle JD Edwards (JDE) Functional Support Analyst responsible for gathering requirements, configuring the ERP (JD Edwards) software performing analysis/design, development, t

Maintenance Technician I|Shift 2

The Fountain Group

Mason, Ohio, USA

Full-time, Contract

Hello, My name is Jack, and I am a Recruiter with The Fountain Group. We are a national staffing firm and are currently seeking a Maintenance Technician for a prominent client of ours. This position is located in Mason, OH. Details of the position are as follows: Job Description: Pay is: $30/hour to Start 3-month assignment, Possibility for extension or conversion based on performance and budget Schedule: [Onsite] Monday through Friday from 03:00pm to 11:00pm Position is mainly responsible

USA|Compliance Professional 2

TalentBridge

Orlando, Florida, USA

Contract

Title: Compliance Professional / Import/Export operations.Location: Orlando, FL 32826 (Accepting candidates in Charlotte, NC 28273, and Houston, TX 77079 as well)Duration: 2-Year Contract (06/09/2025 - 06/08/2027)Start Date: June 9, 2025Onsite Flexibility: 100% OnsiteInterview: Virtual/OnsiteSchedule: Monday to FridayPay Rate: $32/hr on W2Responsibilities:Handle U.S. customs clearance processes and support import/export operations. Prepare and submit customs clearance instructions. Ensure compli

IT Program Manager

AP Ventures

Columbia, Maryland, USA

Contract

Title: IT Program Manager - FDA Location: Hybrid in Columbia, MD Company Background A P Ventures, LLC (APV) is an innovative Woman-Owned Small Business (WOSB) providing services to Government customers at the federal and state levels in three key focus areas: High-End IT Consulting, Emerging Technology and Training Solutions, and Human Capital Services. Established in 2007, APV has completed 70+ prime contracts and currently oversees 25+ task orders, consistently achieving high client satisfact

Electrical Engineer

Innova Solutions, Inc

Lake Forest, California, USA

Contract, Third Party

A client of Innova Solutions is looking for an Electrical Safety Engineer Position type: Contract Duration: 12+ Months Location: Lake Forest, CA (Onsite) As an Electrical Safety Engineer, you will: Minimum Qualifications: Electrical Engineering (or similar) with experience in medical device safety compliance .Expert knowledge of IEC 60601-1 for medical electrical equipment.familiar with FDA Approval processProven experience working cross-functionally with R&D teams and external labs for safety

JD Edwards ERP Analyst

EDI Specialists, Inc.

Houston, Texas, USA

Full-time

The JDE Analyst designs, develops, and supports JD Edwards EnterpriseOne 9.2 applications. This role collaborates with business and IT teams to deliver effective solutions, troubleshoot issues, and optimize system performance. < data-end="313" data-start="282"> Key Responsibilities Design, develop, and document JDE solutions based on business needs. Build, test, and implement custom solutions using JDE development tools. Support and enhance integrations between JDE and other applications. Troub

Biomedical Technician - Onsite

VIVA USA INC

Madison, Wisconsin, USA

Contract

Title: Biomedical Technician - Onsite Mandatory skills: medical imaging, laboratory equipment, electrical circuits, mechanical assemblies, control systems, soldering PCB components, replacing PCB components, diagnostic tools, multimeters, oscilloscopes, hand tools, precision assembly, interpret technical drawings, schematics, manuals, Healthcare equipment, medical imaging systems, X-ray systems, X-ray machines, bone densitometers, lab equipment, laboratory instruments, radiation safety, medical

Staff Software Engineer

Connexion Systems & Engineering

Methuen, Massachusetts, USA

Full-time

Title: Staff Software Engineer Hiring Organization: Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration: Direct HirePay rate: $120k-$155k annuallyJob Location: Methuen, MASchedule: hybrid (3 onsite, 2 remote), M-F, standard business hoursJob#: bh17292 Ideal Candidate Profile: The ideal candidate will have broad-spectrum experience in embedded and application development in the medical device industry, experience writing technical requirements (TSSR), strong skil