- DivIHN Integration Inc (Research Triangle Park, NC)
- …keen attention to detail. Strong understanding of regulatory requirements, including FDA and GMP. Experience with process mapping and flowcharting tools. Proficiency ... with document management systems and Microsoft Office Suite. Strong communication and interpersonal skills with the ability to interact effectively with diverse stakeholders. About us: DivIHN, the 'IT Asset Performance Services' organization, provides… more
- Battelle (Columbus, OH)
- …and federal agencies and their staff. Key clients currently include the FDA , DOD, NIH and VA/VHA.Exhibits a clear understanding of customer requirements to ... ensure exceptional customer satisfaction.Implements, executes, and communicates the policies and strategic emphasis of top management to the business line team.Actively manages major programs and projects to ensure achievement of operational and financial… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:Fidelity Digital Assets ( FDA ) is dedicated to building products and services that help institutions adopt digital assets and innovate within the ... of finance.\u00A0 As a Senior Business Analyst on the FDA Product Delivery team you would have the opportunity...of building engaged and empowered teams The Team The FDA Product Delivery team is central to enhancing and… more
- George Washington University (Washington, DC)
- …and regulations pertaining to privacy and clinical research billing compliance, FDA regulated drug and device trials, and/or clinical research sponsored projects. ... in clinical research contracting with pharmaceutical companies and medical device manufacturers for FDA Direct experience in review of consent forms for FDA … more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/Good Clinical Practice ... review of studies, completing yearly documents required by sponsor, IRB and FDA . Review case report forms. Audit regulatory binders. Ensure timely and accurate… more
- Medline Industries LP (Northfield, IL)
- …expertise in biocompatibility and toxicology. Knowledge / Skills / Abilities Knowledge of FDA requirements and experience with FDA interactions as part of the ... processes Knowledge of CE technical files Working knowledge of FDA and EU MDR and other global medical device...field. Experience of quality audit by external regulatory bodies ( FDA , EU Regulatory body, etc.). Experience in solving practical… more
- DivIHN Integration Inc (Round Lake, IL)
- …Qualifications: Knowledge of cGMP and global regulatory guidelines such as EMA, FDA , and other health agencies. Knowledge of Six Sigma methodology and LEAN ... a plus. Experience -Knowledge of drug manufacturing background and FDA regulations is a must. -It is essential to...audits. -Good knowledge of lab, manufacturing facilities, USDA, and FDA guidelines is required. -Someone who has previously worked… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …conducting clinical research in compliance with the Federal Food and Drug Administration ( FDA ). This position assures that all requirements are met for internal and ... but not limited to, OHRP, DHHS, the Food and Drug Administration ( FDA ), the National Cancer Institute (NCI), Cooperative Groups, pharmaceutical & industry sponsors,… more
- Piper Companies (Philadelphia, PA)
- …experience supporting pre-IND and IND stage regulatory submissions to the FDA Maintains active IND and Clinical Trial applications.Experience submitted to the ... managing regulatory submission workflows, collaborating with various stakeholders, and interpreting FDA requirements as well as current cell and gene therapy… more
- Hired by Matrix (Charleston, SC)
- …to produce satisfactory diagnostic films for interpretation. Knowledge of OSHA, DHEC, FDA and TJC standards and regulations. Responsible for safe operation of ... Required Certification & Licensure Attachments: Skills and Experience Skills: Required FDA IMAGING RADIOLOGY OSHA TEAM PLAYER Additional VASCULAR RADIOGRAPHY PATIENT… more
- DivIHN Integration Inc (Santa Clara, CA)
- …plan; collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity. ... Good Communication Skills Create stats for report writing for FDA Submissions Purpose of Role and Key Requirements /...Analyse data for regulatory submissions and write reports for FDA approval. Required Skills: Preference for a master's degree… more
- Medline Industries LP (Mundelein, IL)
- …of ISO 17025 and CFR requirements; experience interacting with FDA /ISO auditors. Experience applying knowledge and experience working with USP/ASTM/ISO/AAMI/etc ... test methods. Experience applying knowledge of FDA requirements and experience with FDA interactions as part of drug and/or device regulatory approval process… more
- Careerbuilder-US (San Marcos, CA)
- …equipment calibration and maintenance to it is compliant to customer requirements, FDA regulations and ISO specifications. * Ensure the production floor is compliant ... * Schedule, plan, and perform annual internal audits for ISO 9001, ISO 13485, FDA , and AS 9100. Generate the internal audit reports. * Issue Quality Alert and… more
- Medline Industries LP (Northfield, IL)
- …1 year of experience in Quality Assurance and Quality Control in a FDA regulated industry. Experience providing customer service to internal and external customers ... and coordinating concurrent tasks, competing priorities, and critical deadlines. Experience with Microsoft Office Suite FDA regulated industry experience. 798453 more
- Reynolds Consumer Products Inc. (Lake Forest, IL)
- …compliance documentation and submissions to federal agencies, including the FDA .Assist Reynolds' legal counsel with analyzing and substantiating marketing and ... science.Paper and/or plastics industry experience.Regulatory agency experience - particularly FDA , EPA, or analogous state, county, or local government… more
- Alpha Baking (Chicago, IL)
- …all employees, adhering to industry sanitation standards, and ensuring compliance with FDA , SQF, HACCP, FSMA, and GMP standards. This position will report directly ... audit inspection. Ensure compliance with all relevant regulations, including OSHA, FDA , and local health department requirements. Participate in the development of… more
- CMJobPoster (Scarborough, ME)
- …implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Responsible for exhibiting professional behavior ... software; Spreadsheet software and Word Processing software. Working knowledge of FDA , cGMPs/QSR and ISO quality system requirements Strong technical writing skills… more
- Arthrex (Goleta, CA)
- …and standards. Deep knowledge of industry practices. Basic knowledgeable of FDA requirements. Practical knowledge related to the products/components that the ... upon completion for adequacy in meeting objectives. Skills: Experience in application of FDA or ISO guidelines for the investigation and repair of medical devices… more
- Arthrex (Fort Myers, FL)
- …related safety procedures. Knowledge: Basic SAP knowledge preferred. Knowledge of FDA and ISO regulations preferred. Microsoft Office knowledge required (Office, ... fast paced, multilayered work environment preferred. Experience working in an FDA regulated environment preferred. Discretion/ Latitude: Work is performed under very… more
- Integrated Resources, Inc (Rocklin, CA)
- …performance of required tasks in a final production role. . Knowledge of FDA QSRs and ISO 13485 or other related industry standards preferred; experience with ... SAP or other ERP system is strongly preferred. . Previous experience in FDA regulated biotechnology or pharmaceutical environment is strongly preferred. more
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