FDA Jobs

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FDA Lab Scientist (HYBRID)Job Title - FDA Lab Scientist (HYBRID)

NetSource, Inc.Company Name - NetSource, Inc.

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Cornelia, Georgia, USA

Contract

Please note that this is a 1 year contract position. HIGHLIGHTED SKILLS: - Bachelor's Degree required - Hybrid role (will be onsite for at least 3 days) - Performing instrument qualifications and validations - FDA regulated experience - Will perform technical report writing - Will be interacting with suppliers - Experience with Batch Scripts - Must have at least 3 years experience Description: The Scientist will report directly to the Laboratory Supervisor/Manager and will perform routine and c

FDA Validation and IT Quality DirectorJob Title - FDA Validation and IT Quality Director

RSM US LLPCompany Name - RSM US LLP

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Philadelphia, Pennsylvania, USA

Full-time

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there

Proposal Manager / ConsultantJob Title - Proposal Manager / Consultant

Chags Health Information Technology LLC (C-HIT)Company Name - Chags Health Information Technology LLC (C-HIT)

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Columbia, Maryland, USA

Contract

CHIT is seeking an experienced Proposal Manager to join our team of qualified, diverse individuals to lead and win new business pursuits and critical re-competes involving opportunities within the Federal and State government Health IT field and to support business development strategy and operations activities. Responsibilities: Develop and design documents to support the full spectrum of pursuit documents from discussion documents, proposals, and verbal preparation documents Research, write, a

Global Trade Compliance ManagerJob Title - Global Trade Compliance Manager

Ledgent TechnologyCompany Name - Ledgent Technology

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Irvine, California, USA

Contract

Summary: The main function of a Global Trade Compliance Manager is to assess and lead actions required to ensure the compliance of the organization, its Vendors, and entities with all government import, export, and trade compliance laws and regulations globally. Key Responsibilities: * Evaluate, assess and resolve trade compliance issues for Global organization and vendor facilities. * Create and establish strategies and processes for import brokerage and export licensing at global locations. *

Jr. Verification engineerJob Title - Jr. Verification engineer

HCL America Inc.Company Name - HCL America Inc.

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Saint Paul, Minnesota, USA

Full-time

HCLTech is a global technology company, home to 222,000+ people across 60 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG and Public Services. Consolidated revenues as of 12 mo

Proposal Writer/ConsultantJob Title - Proposal Writer/Consultant

Chags Health Information Technology LLC (C-HIT)Company Name - Chags Health Information Technology LLC (C-HIT)

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Columbia, Maryland, USA

Contract

C-HIT is looking for an experienced proposal writer to join our business development and capture teams. The proposal writer creatively presents complex approaches in written and oral proposals for C-HIT clients. The successful candidate plays a vital role in presenting technical, management, past performance, and resume/staffing solutions for business operations, systems integrations, and IT consulting services. Responsibilities: Supports the capture and proposal process by researching and gathe

Software Quality EngineerJob Title - Software Quality Engineer

MindlanceCompany Name - Mindlance

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Lake Forest, Illinois, USA

Contract

Job Title: Software Quality Engineer Location: Lake Forest, IL/ San Diego, CA/ Carlsbad, CA/ Pomona, CA Duration: 12 Months Job Description:The role is expected to cultivate, grow, and maintain core principles including, but not limited to, continuous improvement, self-organization, adaptive planning, and value driven development, using methodologies and frameworks such as LEAN, SCRUM and others. Additionally, you will possess a growth-mindset, be team-oriented, have strong interpersonal skills

BiologistJob Title - Biologist

USAJOBSCompany Name - USAJOBS

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Dauphin Island, Alabama, USA

Part-time

Duties Conducts biological studies as part of a comprehensive risk reduction strategy that encompasses a detailed scientific evaluation of pollution sources. Applies computer fate and transport models to provide insight into the potential impact and risk associated with pollution source impacts to shellfish growing waters. Provides technical assistance to state programs and assesses the appropriateness of existing state water growing area closures. Provides guidance on closure zone determination

Project Manager III (Care Team Performance Consultant)Job Title - Project Manager III (Care Team Performance Consultant)

Innova Solutions, IncCompany Name - Innova Solutions, Inc

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South San Francisco, California, USA

Contract

Innova Solutions is immediately hiring for a(n) Project Manager (Care Team Performance Consultant) Position type: Contract. Duration: 6+ Months Contract (could potentially go longer depending on business need) Location: South San Francisco, CA (Hybrid) The Ideal candidate will have Experience with Strong working knowledge of Clinical Research, Google Cloud Platform, FDA, Electronic Data Capture (EDC), Diabetes Educator (CDCES), Electronic Trial Master File (eTMF), EMR (Athena) As a(n) Project M

Sr. Regulatory Operations SpecialistJob Title - Sr. Regulatory Operations Specialist

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist Coordinate diverse regulatory submissions by collaborating with internal teams and stakeholders, and develop content plans for IND & CTA dossiers. Lead interactions with external publishing teams to compile IND or CTA submissions, including reports and pro

Regulatory Affairs Specialist, Cell & Gene TherapyJob Title - Regulatory Affairs Specialist, Cell & Gene Therapy

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Philadelphia, Pennsylvania, USA

Full-time

Piper Companies is currently seeking a Regulatory Affairs Specialist, Cell & Gene Therapy for an opportunity in Philadelphia, Pennsylvania (PA), to join an innovative biotechnology company creating life-saving cell therapies. Responsibilities of the Regulatory Affairs Specialist, Cell & Gene Therapy Coordinate and manage timing for regulatory submissions, collaborating with internal teams and stakeholders. Oversee external publishing coordination for IND/CTA submissions and related documents.

Quality Systems SupervisorJob Title - Quality Systems Supervisor

Gables Search GroupCompany Name - Gables Search Group

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Tucson, Arizona, USA

Full-time

Seeking Quality Systems Supervisor with experience in manufacturing process controls with experience in injection molding or contract manufacturing. You will be responsible for regulatory requirements; 21 CFR Par 11, 21 CFR Part 820, ISO-13485, regulatory submissions to the FDA and other regulatory agencies. Ideal candidate will have a degree in a discipline related to regulatory affairs with 5 years experience in a regulatory environment, or in quality systems with emphasis in regulatory submis

ECQ EngineerJob Title - ECQ Engineer

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Hopewell Township, New Jersey, USA

Full-time

Piper Companies is currently seeking a ECQ Engineer for an opportunity in Titusville, New Jersey (NJ), to join a global pharmaceutical company. Responsibilities of the ECQ Engineer Maintain, calibrate, qualify and validate equipment used in the production, testing and packaging of pharmaceutical products Develop, execute, and document equipment qualification protocols and test plans in accordance with cGMP regulations and industry standards Commission new laboratory equipment and decommissio

Healthcare Consultant - Life science (Quality Management System)Job Title - Healthcare Consultant - Life science (Quality Management System)

ADDSOURCECompany Name - ADDSOURCE

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Remote or Chicago, Illinois, USA

Third Party

Healthcare Consultant - Life science (Quality Management System) Onsite - Chicago, IL (3-4 days per week) Experience - 14-20 years Must have: Life Sciences consulting experience, Quality (QMS), SDLC & Regulatory (e.g conducting "As-Is" Assessments, "To Be" State definition and Pilot execution), GAMP Job Description 1. Experience in Life Sciences consulting projects related to Quality (QMS), SDLC & Regulatory (e.g conducting "As-Is" Assessments, "To Be" State definition and Pilot execution)

Product Security Solutions Architect / Medical DevicesJob Title - Product Security Solutions Architect / Medical Devices

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Lake Forest, California, USA

Full-time

An international medical device company is looking to bring on a Product Security Solutions Architect to join their R&D Product Security group. You'll work on surgical device products. Ideal candidates have experience working with medical devices or med-tech and have worked with HIPPA/medical device regulations or FDA approval processes. You will play a critical role in ensuring the security of customer-facing products, and lead the design and implementation of security measures for medical devi

Senior Human Factors EngineerJob Title - Senior Human Factors Engineer

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Raynham, Massachusetts, USA

Full-time

A leader in the medical devices and robotics industry is seeking a multi-faceted, talented, user-centered Senior Human Factors Engineer who is driven to make people's quality of life better through compelling, elegant, and intuitive design experiences. For the better part of a century, this group has been focusing on improving surgery procedures and health outcomes across the world. They have a specialty in surgical technologies, orthopedics and interventional solutions, and are driven to impro

Application/Product Security Engineer / Medical DevicesJob Title - Application/Product Security Engineer / Medical Devices

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Lake Forest, California, USA

Full-time

An international medical device company is looking to bring on a Senior Product Security Engineer to join their R&D Product Security group. You'll work on surgical device products. Ideal candidates have experience working with medical devices or med-tech and have worked with HIPPA/medical device regulations or FDA approval processes. You will play a critical role in ensuring the security of their SaMD networks and sensitive patient health information. You'll assess system vulnerabilities, and bu

District Manager, Immunology-Dermatology-Great PlainsJob Title - District Manager, Immunology-Dermatology-Great Plains

Johnson & JohnsonCompany Name - Johnson & Johnson

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Nebraska, USA

Full-time

Description Johnson & Johnson Innovative Medicine is recruiting for a District Manager, Immunology-Dermatology, to support the Great Plains district which includes Nebraska, Kansas and Iowa. 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 Med

Senior Software Engineer- Medical DevicesJob Title - Senior Software Engineer- Medical Devices

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Job Description A medical device manufacturer in Boston is hiring a Senior Software Engineer to their team. As a Senior Software Engineer, you'll be hands on in the development, testing, and design of applications that are used to build critical medical devices used during surgeries. This role is a full-time direct hire and is three-days onsite in downtown Boston. The company specializes in the development and manufacturing of energy-based medical devices that are used during aesthetic procedure

Regulatory AffairsJob Title - Regulatory Affairs

Judge Group, Inc.Company Name - Judge Group, Inc.

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Palo Alto, California, USA

Full-time

Location: Palo Alto, CA Salary: $50.00 USD Hourly - $68.00 USD Hourly Description: Our client is currently seeking a Regulatory Affairs for a 12 month + contract. Hybrid position, 2 days in office (Palo Alto, CA). Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements * Identifies, analyzes and implements country specific requirements necessary for product related submis