- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) driving...+ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead… more
- Sanofi Group (Morristown, NJ)
- …setting clear expectations for the device regulatory strategy, including a global labeling strategy + Ensures alignment and communication internally and ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** :...teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices … more
- AbbVie (North Chicago, IL)
- …Review Safety Data Information for Instructions for Use (IFU) to ensure accurate device labeling New Product ( Device , Combo, IVD) Development Participates ... other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety oversight relevant to...on a contemporaneous basis. + Provide medical leadership on global teams on safety related issues. + Responsible for… more
- Lundbeck (Deerfield, IL)
- …+ Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. + Knowledge of development and registration ... Director US Regulatory Global Strategic Labelling...labeling challenges during development and post-approval maintenance of global labelling activities, ensuring cross functional communication and execution… more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Lilly (Indianapolis, IN)
- … Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA- Devices , GRA-RD&E, and GRA- Global Labeling and Product Communications. ... a global regulatory strategy which supports product (including delivery device and relevant medical devices ) development, registration, and lifecycle… more
- Merck (West Point, PA)
- **Job Description** The Director , Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global ... equipment-based challenges when required. The technical lead may also manage global infrastructure projects to establish, upgrade, and improve the GCS packaging,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulatory submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and ... Summary** **Job Description** BD is one of the largest global medical technology companies in the world and is...self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support of global marketing of company products for Infusion Sets. This role reports to the Senior ... makers of possible!** BD is one of the largest global medical technology companies in the world. _Advancing the...best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and… more
- Candela Corporation (Marlborough, MA)
- …MA** State/Territory **Massachusetts** **Company Overview:** Candela Corporation is a leading global aesthetic device company with a comprehensive product ... personal relationships even in heated or difficult/dynamic circumstances. . Global accountability for Design/Supplier Quality performance, Sterilization/ Labeling … more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Description** We are **the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health (TM) is ... possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve....Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs** will provide regulatory support for… more
- Amgen (Cambridge, MA)
- …processing and manufacturing of injectable drugs in vials, syringes, cartridges, devices , disposables, and the associated GMP/ Device documentation and regulatory ... Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will do** Let's… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …Skills + Excellent communication skills including: verbal, reading and writing. + Use various labeling software tools such as TVT and/or Global Vision. Can be ... Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood...conversion to OTC or OTC Monograph direct including any labeling reviews and updates. + Ensure all manufacturing, packaging,… more
- Medtronic (Minneapolis, MN)
- …Day in the Life** We are seeking a strategic, experienced, and proactive Compliance Director to help design and build the global compliance program for Medtronic ... Diabetes - a $2.8 billion medical device business that has recently announced that it will...Reporting to the company's Chief Compliance Officer, the Compliance Director will play a pivotal role in helping the… more
- GRAIL (Olympia, WA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual… more
- Sanofi Group (Morristown, NJ)
- …relationships with FDA are established and maintained. + Provides input into the global organization for labeling strategies of marketed drugs. + Demonstrates ... **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Edwards Lifesciences (Irvine, CA)
- Imagine how your ideas and expertise can change a patient's life. Our Global Supply Chain team plays a central part in ensuring our products are delivered to ... to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling ,… more
- J&J Family of Companies (Titusville, NJ)
- …for humanity. Learn more at https://www.jnj.com/. **POSITION SUMMARY:** The Senior Director , Clinical Leader (CL) is responsible for development and execution of ... study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project… more
- Abbott (Abbott Park, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Director , Information Governance** Abbott is a global healthcare leader that ... Abbott is a global healthcare leader that helps people live more...healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals, and branded generic medicines. Our 115,000 colleagues… more
- Merck (West Point, PA)
- **Job Description** The Global Clinical Supply (GCS) organization within our company's Research Laboratories manages the end-to-end clinical supply chain for the ... and 200+ External Collaborations). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more… more
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