- 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
- Medtronic (Washington, DC)
- …RoHS, SCIP) + Experience in counseling on US Food and Drug Administration ( FDA ) regulatory requirements + Experience in conducting reviews of advertising and ... on notices of violation, complaint letters,findings and other regulatory authority requirements related to manufacturing operations and product sales and marketing.… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, ... electronic drug listing for applicable drugs in accordance with federal requirements and guidance documentsIdentify changes needed for FDA - approved… 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 ... regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer… more
- Kedplasma (Cocoa Beach, FL)
- …KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory ... within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...requirements . + Holds regular meetings with Quality Assurance Manager (QAM) and Center staff for revisions and updates… more
- Sysco (Houston, TX)
- …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
- University of Colorado (Aurora, CO)
- …corrective action when necessary + Understand and keep abreast of all relevant regulatory requirements , including but not limited to FDA , EMA, ICH, GCP, and GLP ... **Research Services Manager ** **Description** **University of Colorado Anschutz Medical Campus**...procedures to ensure that they are consistent with regulatory requirements + Develop and update compliance policies and procedures… 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
- Dentsply Sirona (Lancaster, PA)
- …in an ISO setting + Manufacturing experience + Working knowledge of FDA requirements + Positive "can do" professional attitude. Dentsply Sirona ... network. + Implements and maintains QMS to ensure the compliance with FDA regulations, Corporate QA/RA, and internal requirements . + Conducts/contracts internal… 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
- 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
- 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
- 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
- Kedplasma (Sanford, FL)
- …KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory ... and certifications. **JOB SUMMARY** Assists and supports the Center Manager in the daily operations of a plasma collection...within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… 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
- Biomat USA, Inc. (Amarillo, TX)
- …services in more than 110 countries and regions. **JOB TITLE:** ASSISTANT MANAGER **POSITION SUMMARY:** Assists with operational management of a Plasma Collection ... and overall performance and profitability of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone for days at a time.… more
- Abbott (Des Plaines, IL)
- …work environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements , Company policies,operating procedures, ... 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
- Envista Holdings Corporation (Quakertown, PA)
- …professional relationships across the organization. **POSITION SUMMARY** The **Quality Assurance Manager ** (QA Manager ) is responsible for leading the Quality ... the work of staff in this area. The QA Manager oversees post-market data for product and process improvement...related to our medical devices in compliance with regulatory requirements and within process timeframes. + Analyzing and reporting… more