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

Role: Regulatory Engineer Location: Milwaukee, WI Experience: 6 Job Description: Responsibilities Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations. Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com

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

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

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

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only 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 su

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r

Job Description- Lead and mentor development team members on best practices. - Develop applications using Appian and integrate with COTS products. - Implement Appian and web-based applications. - Create design documents, target state diagrams, and instructions. - Build Appian applications and integration components in Java. - Provide technical guidance to mid-level developers as needed. - Participate in meetings for design reviews and troubleshooting. - Collaborate with release manager on deploy

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s

We anticipate the application window for this opening will close on - 24 Jun 2025 Position Description: Sr. R&D Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Multiple positions available. Responsible for providing R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class medical devices (bare-metal or

About Beacon Systems, Inc Beacon Systems, Inc, delivers Program Management, Science, Engineering, and Technology Solutions to Federal, Commercial, State, and Local Agencies. We are a subsidiary of Radiant Digital Solutions. Our Technology support to many DoD Agencies, NASA, Voice of America, FDA, and State Agencies such as State of FL, RI, MS, ND, VA, and WV extends our delivery of solutions worldwide. Position Title: Hybrid UX Designer / UX Writer Duration: Long Term Location: Remote- Orlando,

Piper Companies is seeking a Clinical Research Associate (CRA) with experience in Oncology clinical trials to join a reputable clinical research organization. This is a full-time/permanent opportunity. Some travel is required (regionally, about 8-10 days out of the month). Candidates must be located in CST or PST in one of the following states: WY, CO, KS, WI, IN, OH, MN, MO, IL, MI, KY, AR, CA, OR, WA, NV, UT, AZ. Responsibilities of the Senior Clinical Research Associate (CRA): Perform site s

Job Description Summary About GE Healthcare's Bone and Metabolic Health (BMH) Business: GE Healthcare's BMH business focuses on delivering innovative diagnostic solutions for bone health and metabolic diseases, including Dual-energy X-ray Absorptiometry (DXA) systems and advanced imaging technologies. Our mission is to improve patient outcomes through cutting-edge medical devices and software that empower clinicians worldwide. Job Summary: We are seeking a skilled Test Engineer to join our Bone