- Aldevron (New York, NY)
- …essential requirements of the job include:5+ years of relevant experience in drug product label/ labeling required,Experience with labeling equipment ... be a part of the Operational Quality Assurance team and report to the Sr . Manager, Operational QA, responsible for Developing and implementing labeling processes… more
- Danaher Corporation (New York, NY)
- …essential requirements of the job include: + 5+ years of relevant experience in drug product label/ labeling required, + Experience with labeling equipment ... be a part of the Operational Quality Assurance team and report to the Sr . Manager, Operational QA, responsible for Developing and implementing labeling processes… more
- Merck (Rahway, NJ)
- …portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... develops mitigation strategies for review with clinical partners and senior leaders. + Works directly in the SAP system...consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). + Responsible for… more
- Endo International (Rochester, MI)
- …helping everyone we serve live their best life. **Job Description Summary** The Senior Quality Specialist , Stability is responsible for overseeing the stability ... of time_ AccountabilityResponsibilities% of TimeStability + Oversees the receiving and labeling of new stability samples of submission, validation, pilot and… more
- Stryker (Weston, FL)
- We are seeking a ** Senior Regulatory Specialist ** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid two ... per week in Mahwah, NJ or Weston, FL. **What you will do** As the ** Senior Regulatory Affairs Specialist ** , you will support Stryker's Mako and Enabling… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies ... team for agency filing + Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance… more
- Medtronic (Fridley, MN)
- …travel to enhance collaboration and ensure successful completion of projects. The Senior Medical Safety Specialist is responsible for providing medical expertise ... assigned products and therapies, such as device design and function, product labeling , indications, mechanism of action, care pathways, and overall safety profile… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... new or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III...Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of approved PMAs,… more
- Abbott (Plymouth, MN)
- …health and get on with their lives. **The Opportunity** We are recruiting for a ** Senior Regulatory Affairs Specialist ** to join our team on-site in our St. Paul ... new or modified, are distributed to appropriate personnel. + Reviews device labeling and marketing materials for compliance with FDA submissions and applicable… more
