- Vanderbilt University Medical Center (Nashville, TN)
- …requirements. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible ... **Organization:** Director's Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our LDT efforts and… more
- Mentor Technical Group (College Station, TX)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Functions: + Provide engineering, troubleshooting support and technical expertise for process equipment and site utilities as needed. + Proactively identify… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …COR), FDA management personnel, and customer representatives. The Program Manager will be responsible for execution and performance of contract and responsible ... goals and make vision a reality. Project Description: The FDA is composed of multiple Centers and Offices. Each...Job Summary: We are seeking a proven BPA Program Manager with prior experience leading and managing an enterprise… more
- Olympus Corporation of the Americas (San Francisco, CA)
- …outside US. The Manager , Sr. Global MDR Submission communicates with the FDA or other interested internal and external parties as needed. This position will also ... other than @Olympus.com, it is likely not legitimate._ **Job Description** The Manager , Senior Global MDR Submission is responsible for managing Market Quality- COE… more
- Stanford University (Stanford, CA)
- Research Process Manager (Grants Officer) **School of Medicine, Stanford, California, United States** Finance Post Date Dec 09, 2024 Requisition # 104981 ... Research Management Group is seeking to hire a Research Process Manager . The Research Management Group has...regulation (eg OMB Uniform Guidance, Cost Accounting Standards, Medicare, FDA , OHRP). + Ability to understand and interpret university… more
- Takeda Pharmaceuticals (Columbus, OH)
- …to inspire you and empower you to shine? Join us as a Senior Manager , Integrated Clinical Trial Data Process Excellence and Delivery based remotely reporting ... a necessary contributor to our inspiring, bold mission. **_GOALS:_** + The Senior Manager , Process Excellence and Delivery supports the strategy to develop and… more
- University of Michigan (Ann Arbor, MI)
- Regulatory Project Manager Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first page of your ... and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus...minimum of seven calendar days. The review and selection process may begin as early as the eighth day… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as a Senior Manager , Clinical Site Startup and Engagement Process Excellence & Delivery based remotely ... By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application… more
- Kedplasma (Cocoa Beach, FL)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as...units. + Oversees the plasma shipments and sample submission process to ensure accuracy and timeliness of shipments. +… more
- Sysco (Houston, TX)
- **JOB SUMMARY** The Manager , Food Safety Program (Food Safety Program Manager (FSPM)) is responsible for providing proactive leadership and instruction in Food ... Site(s). Sites are assigned to FSPMs based on risk and complexity. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation… more
- Integra LifeSciences (Plainsboro, NJ)
- …to advance patient outcomes and set new standards of care. The Project Manager is responsible for leading cross-functional teams in the planning, direction and ... communication with stakeholders in manufacturing, quality, engineering, product development, process technologies to ensure value stream performance to support … more
- BeiGene (San Mateo, CA)
- …by collaborating with cross functional teams (eg RegTech, RA, GTS, QA). The Sr. Manager IDMP, RIM, will have primary focus on IDMP related initiatives (eg SPOR) as ... for management of centralized RIM data entry needs, inclusive of IDMP attributes, process & guidance. + Ensure adherence to RIM data quality standards and compliant… more
- University of Colorado (Aurora, CO)
- **Research Services Manager ** **Description** **University of Colorado Anschutz Medical Campus** **Department: Surgery** **Job Title: Research Services Manager ** ... Department of Surgery + Financial management of the closeout process for all clinical trials under the purview of...all relevant regulatory requirements, including but not limited to FDA , EMA, ICH, GCP, and GLP guidelines + Oversee… more
- BioFire Diagnostics, LLC. (Durham, NC)
- Position Summary: The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring ... (eg, QSR and ISO9001/ISO13485). This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. QC Microbiology/EM… more
- Medtronic (Los Angeles, CA)
- …their diabetes easier and more connected. In this exciting role as an Engineering Manager , you will have responsibility for managing a team of hardware and ... process engineers involved in the development and commercialization of...Have** + Experience working in a regulated industry (eg, FDA -regulated) + Master's Degree in Engineering, Quality, Regulatory, or… more
- Dentsply Sirona (Lancaster, PA)
- …-by helping improve oral health worldwide. Job Summary: The QA Manager is responsible for development and implementation Quality system processes including ... + Ensures visibility of upcoming changes/activities that could potentially lead to process quality and regulatory risk. + Supports the implementation of a harmonized… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Sr Manager Regulatory Affairs represents regulatory affairs for device development and/or ... and submitted on time. Directs communication and interactions with US FDA /Notified Bodies, as primary contact for the related projects. Utilizing detailed,… more
- Takeda Pharmaceuticals (Lexington, MA)
- By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application ... is true to the best of my knowledge. **Job Description** **Senior Manager , US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA or… more
- Kelly Services (Seattle, WA)
- Kelly(R) Science & Clinical is seeking a Manager , CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage biotechnology ... **Salary:** $130,000-160,000/year **Workplace:** Onsite in Seattle, WA **Overview** The Manager , Regulatory Affairs (CMC) is responsible for providing regulatory… more
- Abbott (Des Plaines, IL)
- …and driving continuous improvement of, related quality assurance programs, policies, process , procedures and controls. + Manage the Supplier Quality Operations. + ... SOPs and procedures. + Ensure timely and thorough review of product/ process changes. + Provide timely performance & developmental evaluations of departmental… more