FDA Jobs

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FDA/Regulatory/Lab/Junior EngineerJob Title - FDA/Regulatory/Lab/Junior Engineer

Cybertec, Inc.Company Name - Cybertec, Inc.

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Saint Paul, Minnesota, USA

Contract

Role: FDA/Regulatory/Lab/Junior Engineer Location: St. Paul, Minnesota location Duration- 12 months Bachelors in Engineering (Computers, Electrical, Bio-medical or any other related). Master s degree in a relevant field is preferred.Minimum of 1-2 years of experience in the medical device domain or related industry. Experience in verification/testing is preferred.Good Documentation and communications skills to perform test method development, technical report writing and client interactions.Stro

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 SW Quality EngineersJob Title - FDA SW Quality Engineers

Kforce Technology StaffingCompany Name - Kforce Technology Staffing

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San Diego, California, USA

Full-time

RESPONSIBILITIES: Kforce's client, a growing and established Medical Device Company is seeking a Medical Device Software Quality Engineer in San Diego, CA. We are working directly with the Hiring Manager on this search assignment. The company offers a competitive compensation including base salary, annual bonus, and a generous Stock/RSUs Plan. The candidate must reside in the San Diego metro area. This position is Hybrid Remote. Responsibilities: * Medical Device Software Quality Engineer will

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

AI DeveloperJob Title - AI Developer

iTek People, Inc.Company Name - iTek People, Inc.

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New Jersey, USA

Full-time, Contract, Third Party

Hi, Hope you are doing well! Please find the below job description and let me know if you are interested, thank you. Job Title: AI Developer Work Location: JFK Parkway, NJ (Remote) Duration: Long term Job Description: Position Summary / Objective: Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives. Responsibilities: Develop global or US regulatory st

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

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

Hardware Pen Tester / Medical DevicesJob Title - Hardware Pen Tester / 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 hire a Penetration Tester to join their R&D Product Security group. You'll work on surgical device products. Ideal candidates have experience penetration testing hardware, and experience with medical devices is a big plus. This role is remote PT hours with occasional travel into Orange County for device testing. This role is a 6-12 month contract to hire position. Required Qualifications 1+ year of experience working in product security 1+ ye

Product Security Engineer / EmbeddedJob Title - Product Security Engineer / Embedded

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 hire a Product Security Engineer to join their R&D Product Security group. You'll work on surgical device products, working with a blend of application security and hardware/firmware/connected softwares. Ideal candidates have experience with embedded software, application security, and DAST/SAST tools - experience with medical devices is a big plus. This role is on-site in Lake Forest, CA. Required Qualifications 4+ year of experience working

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

Sr Manager of Product Management - Medical Aesthetic Devices (Hybrid)Job Title - Sr Manager of Product Management - Medical Aesthetic Devices (Hybrid)

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

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Boston, Massachusetts, USA

Full-time

This company in the medical aesthetics devices space is looking for a Senior Manager of Product Management to join their team. They provide devices for treatments such as laser hair removal, wrinkle removal, and tattoo removal. This would be a full-time role with a hybrid schedule of 2-3 days/week in their office in Marlborough, MA. In this role, you will work very closely with engineering teams, marketing, regulatory, R&D, and more to lead the full end-to-end product management process for both

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)

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