- 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
- TestPros (Silver Spring, MD)
- …Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 ... Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to...to lead our QA efforts in responding to an FDA project. The ideal candidate will have a strong… 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 Oct 21, 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
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …+ Establish and maintain production processes ensuring instrument production meets company, FDA , and customer specifications + Carries out process improvement, ... **Job Description Summary** Serves and leads a team of process engineers responsible for managing the tactical and strategic Safety Quality Delivery and Costs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory...the RPM group by sharing best practice and escalating process and operational issues in a timely manner and… more
- Sysco (Pleasant Grove, CA)
- **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
- Lundbeck (Deerfield, IL)
- Senior Manager Regulatory Strategy - Remote Opportunity Requisition ID: 5804 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... greater United States. Preferably East Coast or Midwest.** **SUMMARY:** The Senior Manager , Regulatory Strategy (US RA): supports the creation and implementation of… more
- Keurig Dr Pepper (Frisco, TX)
- The Regional Quality Manager for DSD is responsible for providing Corporate Quality support to our DSD region for Cold Beverage Manufacturing locations - they will ... products as defined by FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect up to 50% travel to… more
- Unilever (San Francisco, CA)
- THE ROLE: REGULATORY AFFAIRS MANAGER You are a compliance expert with roots in the supplement industry and have a passion for supporting the innovation of uniquely ... compliance, advertising, and marketing of OLLY products. The RA Manager will serve as the company's operational expert on...and provide regulatory expertise to ensure compliance with applicable FDA and FTC regulations. + Use risk management… 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
- 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
- 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
- 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
- Arkema (Memphis, TN)
- Quality & Compliance Manager Job Location: Memphis, TN, United States Employment Type: Regular Category: Production / Operations Posting Date: Nov 21, 2024 Division: ... Oxygenes & Derivatives Location: Memphis Title: Quality& Compliance Manager Situation in Organization This position reports to the... ensures that the plant maintains compliance with all FDA (drug and food), ISO, and AIMS (Arkema Integrated… more
- General Dynamics Information Technology (Washington, DC)
- …As the IT Delivery Manager , you will play a pivotal role in FDA 's IT modernization by ensuring the seamless execution and delivery of IT projects. This ... General Dynamics Information Technology is seeking to fill an **IT Modernization Delivery Manager ** , role on an existing contract to support the **Food and Drug… 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