- 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
- RWJBarnabas Health (West Orange, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... equipment. Assists with new equipment installations as assigned. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements… more
- RWJBarnabas Health (Livingston, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... equipment with competence appropriate to job proficiency level. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements… more
- MyFlorida (Fort Lauderdale, FL)
- …as necessary or required. + Maintains Continuing Education Units, Certified Food Manager Certification, FDA standardization and Florida driver's license. + ... Maintains state issued equipment in proper working condition. + Participates in meetings and training sessions as required. + Provides a high standard of customer service. + Performs other work as required. Knowledge, Skills, and Abilities + Knowledge of laws… more
- Novo Nordisk (Plainsboro, NJ)
- …and SPL) + May be responsible for managing projects, processes, or programs with manager oversight + Knowledge of FDA and Health Canada eCTD submissions ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… 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)
- …Public Trust Clearance Job Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to an FDA project. ... candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality… 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
- 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 lead (GRL), US regulatory lead… 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
- 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
- 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
- Cardinal Health (Columbus, OH)
- …documents, including INDs, NDAs, BLAs, CTAs, and other filings to regulatory authorities ( FDA , EMA, etc.). + Manage and ensure timely submission of regulatory, and ... + **Regulatory Compliance** + Ensure ongoing compliance with applicable regulations (eg, FDA , EMA, ICH, GxP) throughout the life cycle of clinical development. +… 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)
- The Regional Quality Manager for DSD is responsible for providing Corporate Quality support to our DSD region for Cold Beverage Manufacturing locations - they will ... FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect...operating in compliance with KDP Policy & Procedures, FSMA, FDA GMP, and GFSI guidelines. + Support site incident… 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
- Amneal Pharmaceuticals (Brookhaven, NY)
- Description: The Manager , Regulatory Compliance, assembles a team for site wise and/or cross departmental discussions, oversees investigation, and completes Field ... warrant notification to The Food and Drug Administration. The Manager , Regulatory Compliance is responsible for leading activities for...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field… more
- United Airlines (Chicago, IL)
- …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 ... and contract caterers to meet applicable US regulatory requirements ( FDA , USDA, CBP, IFSA, ITP, and DOD) and international...appropriate based on location. This role supports the Sr. Manager - Food Safety with conducting audits of facilities,… 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 ... Technology is seeking to fill an **IT Modernization Delivery Manager ** , role on an existing contract to support...DMV 2x a week **Preferred Skills and Experience:** + FDA experience is strongly preferred + Prior HHS experience… more
- Abbott (Des Plaines, IL)
- …environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies,operating procedures, processes, and ... contractors, and vendors. + **Serve as SQA SME during FDA , ISO and other audits** . + Strong knowledge...**5 years Related to supplied product quality within an FDA /ISO certified environment.** + Multi-tasks, prioritizes and meets deadlines… more