- Vanderbilt University Medical Center (Nashville, TN)
- …. . The VUMC Laboratory Quality Management Department is in need of an FDA Regulatory Affairs Manager to join the team! **This position is eligible ... Administration **Job Summary:** Leads VML's responses to the recent FDA LDT regulations. Develops a team to support our...ways to resolve them. - Fulfills Safety and Regulatory Requirements : Understands all aspects of providing a safe environment… 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)
- …team of QA professionals, and ensuring all products and services comply with FDA requirements . Key Responsibilities: + Oversee the development and implementation ... accuracy in testing and documentation. + Regulatory Knowledge: In-depth understanding of FDA regulations and compliance requirements . + Leadership: Ability to… 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
- Sysco (Pleasant Grove, CA)
- …and complexity. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation of the requirements , policies, procedures (SOPs), ... food safety. The Manager , Food Safety Program (Food Safety Program Manager ) oversees the implementation of the requirements , policies, procedures, programs,… 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
- BioFire Diagnostics, LLC. (Durham, NC)
- …+ Ensures laboratory equipment is in compliance with procedures and GLP requirements . The QC Microbiology/EM Laboratory Manager is responsible for making ... Position Summary: The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the...are appropriately measured and monitored according to quality system requirements (eg, QSR and ISO9001/ISO13485). This position is in… more
- Cardinal Health (Columbus, OH)
- …demonstrated leadership responsibilities, preferred. + Strong knowledge of global regulatory requirements ( FDA , EMA, ICH, etc.) and clinical trial regulations. ... Affairs (Clinical Submissions)_ is responsible for ensuring compliance with regulatory requirements for clinical trials and products. This role involves providing… 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
- Keurig Dr Pepper (Frisco, TX)
- …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% ... The Regional Quality Manager for DSD is responsible for providing Corporate...operating in compliance with KDP Policy & Procedures, FSMA, FDA GMP, and GFSI guidelines. + Support site incident… more
- Unilever (San Francisco, CA)
- …with dietary supplement experience strongly preferred. + Extensive knowledge of FDA , FTC, and USDA's regulatory requirements and compliance in dietary ... THE ROLE: REGULATORY AFFAIRS MANAGER You are a compliance expert with...dietary supplements. You have extensive knowledge of the regulatory requirements to make substantiated label and marketing claims. You… 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
- United Airlines (Chicago, IL)
- …& Lounges, hospitality partners, and contract caterers to meet applicable US regulatory requirements ( FDA , USDA, CBP, IFSA, ITP, and DOD) and international ... place to work. Are you ready to travel the world? **Key Responsibilities:** The Manager Food Safety will own the United Airlines Food Safety & Quality Assurance… more
- Medtronic (Los Angeles, CA)
- …knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements . + FDA regulatory experience- eg, presenting during FDA ... 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… more
- Arkema (Memphis, TN)
- …of process changes, and occasionally developing analytical methods as quality requirements increase. The Quality and Compliance Manager role includes ... Quality & Compliance Manager Job Location: Memphis, TN, United States Employment... ensures that the plant maintains compliance with all FDA (drug and food), ISO, and AIMS (Arkema Integrated… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **Senior Manager , US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** **Lexington, MA or ... PA** **About the role:** Join Takeda as a Senior Manager , US Medical Ad/Promo Regulatory Review where you will...where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- …on budget, headcount, resource and capacity utilization and project timelines. The manager will work directly with R&D Packaging Engineering and packaging suppliers ... design and material qualification, closure integrity and adherence to ISO, FDA and other domestic and international regulations pertaining to packaging systems.… more
- Keurig Dr Pepper (Sacramento, CA)
- Relocation Assistance is Available The QEHS Manager is accountable for the Quality and Environmental, Health and Safety Program at the site. Direct report to the ... Plant Director, the QEHS Manager provides site leadership in Food Safety, Quality Assurance,...six sigma Quality performance, and 100% compliance to all FDA , EPA and OSHA regulations. **Location:** This position is… 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
- BeiGene (Emeryville, CA)
- …+ Ensure regulatory submissions are maintained in compliance with regulatory requirements . + Address device inquiries from FDA /HAs, IRBs/sites, and ... **General Description:** The Senior Manager , Regulatory Diagnostics will lead the development, planning,...FDA structure and functions; knowledge of/experience with regulatory requirements for other regions also desirable. + Proven ability… more