FDA Jobs

1 - 20 of 417 Jobs

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

NetSource, Inc.Company Name - NetSource, Inc.

•

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

•

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

Information Technologist (Enterprise Architect), Center for Biologics Evaluation and Research (CBER), FDAJob Title - Information Technologist (Enterprise Architect), Center for Biologics Evaluation and Research (CBER), FDA

Food and Drug Administration (FDA)Company Name - Food and Drug Administration (FDA)

•

Remote or Silver Spring, Maryland, USA

Full-time

Duties/ResponsibilitiesThe Information Technologist (Enterprise Architect) of the Office of Regulatory Operations (ORO) reports to the ORO Director. The Information Technologist (Enterprise Architect) develops and facilitates the implementation of a CBER enterprise informatics architecture as captured in associated roadmaps and other documents. The incumbent provides technical understanding of information technology to business staff, technical staff and others, to drive a CBER-wide enterprise a

Proposal Manager / ConsultantJob Title - Proposal Manager / Consultant

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

•

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

•

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. *

Proposal Writer/ConsultantJob Title - Proposal Writer/Consultant

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

•

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

Medical Device Quality EngineerJob Title - Medical Device Quality Engineer

Talent GroupCompany Name - Talent Group

•

Westborough, Massachusetts, USA

Contract

5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.Familiarity with product development lifecycles, including design change and document change control.Competence in process verification and validation methodologies.Proficient in using word proces

JD Edwards E1 developerJob Title - JD Edwards E1 developer

PamTen IncCompany Name - PamTen Inc

•

Remote

Contract

Experience with JD Edwards E1 9.1, 9.2 Experience with Oracle JD Edwards E1 tools: RDA, FDA, BDA, and TDA Experience with JDE Orchestrator, UX One, BSFN and BI Publisher Confident and comfortable creating UDOs (E1 Pages, OneView, Watchlists, etc.) Capable of creating advanced queries using SQL, DML, and DDL for data analysis, user requests, and KPIs Advanced knowledge DevOps / SDLC methods including release strategy Knowledgeable on DB schema design Experience with and an understanding of interf

Project Engineer (CAPEX)Job Title - Project Engineer (CAPEX)

KelltonCompany Name - Kellton

•

Houston, Texas, USA

Contract

Job Title: Project Engineer Location: Houstan, TX Must have Capital expenditure or capital expense experince (capex, CAPEX, or CapEx) Description: The Project Engineer role supports ongoing operations by providing technical leadership as it relates to manufacturing and process systems. The role acts as a technical resource to operations customers to ensure that equipment and facilities are designed, operated, and maintained to meet production needs. Responsibilities of the role include impleme

BiostatisticianJob Title - Biostatistician

Talent GroupCompany Name - Talent Group

•

Remote

Contract

Comprehensive SAS programming skills (Proficient in BASE, STAT, MACRO and GRAPH)Capable of directing and promoting teamwork in a multi-disciplinary team settingCapable of reviewing current processes and identify potential process improvementsComprehensive understanding of a wide variety of clinical trials/designs and corresponding reporting of dataIn-depth understanding of interpreting the results from statistical analyses of complex dataStrong project management skills, as shown through managem

Food Development TechnologistJob Title - Food Development Technologist

Agile Global Solutions, IncCompany Name - Agile Global Solutions, Inc

•

San Clemente, California, USA

Full-time

Notes: Heavy PMWorking with the chef, finance, commercializationGetting a product ready for launchProduct costingsSourcing new ingredientsEvaluating new ingredientsTroubleshoot technical problems/issues with the product (i.e. how to reduce cost, too high in the tray how to resolve without compromising the product)Regulatory Food Compliance FDA/USDACal Poly grads usually have a good backgroundUse of Genesis. Can run nutritional panelsCandidate must have 3-5 years related experience05/20 start -

AI DeveloperJob Title - AI Developer

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

•

New Jersey, USA

Full-time, Third Party, Contract

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

Computerized Systems Validation BSAJob Title - Computerized Systems Validation BSA

TRUGlobalCompany Name - TRUGlobal

•

Alameda, California, USA

Full-time

This is Karthik from TRuGlobal. TRuGlobal is looking for a strong Sr.Business Analyst for a Onsite position in Alameda, Please reply back with the updated resume if you re interested with below position to Position Details: Title: Sr. Business Analyst -level Location: Alameda, CA Onsite Type of position: 6+ Months Contract-to- Hire OR Full-time Direct Client General Summary: The Sr Business Systems Analyst will assure that validated computerized systems are implemented, maintained, and obsole

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

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

•

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

•

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

•

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

Quality Systems SupervisorJob Title - Quality Systems Supervisor

Gables Search GroupCompany Name - Gables Search Group

•

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

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

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

•

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.

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

•

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

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

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

•

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