- Abbott (Maple Grove, MN)
- Abbott is a global healthcare leader that helps people...RA QA Specialist is to combine the knowledge of Regulatory , Quality and Compliance to lead and ... Quality Senior Specialist position would be structured under the Global Regulatory Services (GRS) function managing projects...Regulatory Review + EU and US medical device compliance + Project management skills - organize and host… more
- IQVIA (Washington, DC)
- **Position Overview** **MCRA, an IQVIA business is seeking a Vice President, Spine Regulatory Affairs to be a critical team member and Company leader supporting ... regulatory strategy and submissions for the firm's spine clientele....required.** **Collaborate with other MCRA departments, including clinical, RHEMA, compliance , and quality assurance.** **Collaborate with other department heads… more
- Sanofi Group (Morristown, NJ)
- … compliance with validation and cybersecurity standards. ** Regulatory & Quality Compliance ** + Ensure global compliance with regulatory ... centralized model will enable Sanofi to maintain agility, ensure regulatory compliance , and drive innovation as we...industry in digital artwork transformation. We are an innovative global healthcare company with one purpose: to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …role involves developing and implementing practices for SaMD devices to ensure regulatory compliance , expedition of product clearances and maintain the highest ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …inputs (including all documents required under risk files.) + Knowledge of global Regulatory Affairs requirements, regulations, and standards + Strong ... Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint....Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management… more
- GRAIL (Menlo Park, CA)
- …DC, North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more ... plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing… more
- Abbott (Santa Clara, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...and review process to ensure submission approval + Ensure compliance with US and global product post… more
- Sumitomo Pharma (Madison, WI)
- …**Director, Regulatory Advertising & Promotion** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more
- Edwards Lifesciences (Irvine, CA)
- … strategic plans + Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and ... domestic and international product submissions + Full knowledge and understanding of global regulatory requirements for new products or product changes +… more
- Rhythm Pharmaceuticals (Boston, MA)
- …of operations resources for submission documents + Identify new or revised regulatory policies and initiate activities to support compliance + Participate ... Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare… more