- Cytiva (Pensacola, FL)
- …Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device , Biopharma, or other FDA or EPA-regulated ... Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.Quality Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Takeda Pharmaceuticals (Boston, MA)
- …progress/results to leadership teams + Monitor and interpret relevant global and local medical device regulatory developments, assessing their impact on ... aimed at maintaining oversight over the safety of Takeda medical devices ; be they as stand-alone or... Medical Safety, LOCs, Global Clinical Development, Global Regulatory Affairs, Device Quality, PV Compliance etc.… more
- Sanofi Group (Morristown, NJ)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... Care Combination Products, who in turn reports to the Head of GRA Device . The candidate will...to internal regulatory processes and procedures for medical devices and combination products. + Engage… more
- Aerotek (Irvine, CA)
- **Cleanroom Operator** + This position is responsible for the production of high-quality medical devices within a manufacturing cell. + Working under close ... test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. + The role requires spending 95% of… more
- J&J Family of Companies (Santa Clara, CA)
- …clinical trials and existing requirements for sponsors of clinical investigations involving medical devices . + Partner with Operations and Process Excellence to ... but not limited to R&D, Supply Chain/Manufacturing, Clinical and Medical Affairs, Regulatory Affairs, Service, Marketing, in...regulated industry with at least 12 years in a medical device industry. + Minimum 10 years… more
- J&J Family of Companies (Irvine, CA)
- …- External** + Board Certified MD with practical Cardiology experience + Class III Medical Device experience is required + Experience in an academic clinical / ... regulatory requirements, and healthcare compliance + Strong understanding of medical device development processes and lifecycle management + Excellent… more
- Astellas Pharma (Northbrook, IL)
- …This position manages a team of up to 5 direct reports and reports to the Head of PRTL Packaging and Device . + Directs and maintains a packaging technology ... world. We are committed to turning innovative science into medical solutions that bring value and hope to patients...issues and decisions. + Creates and implements packaging and device procedures and standards to meet regulatory … more
- Philips (Plymouth, MN)
- …10 years of industry experience, in a highly regulated environment of Medical Devices , Automotive, Aerospace, etc. Medical Device preferred. + Must be ... ** Head of Integrated Supply Chain Quality, IGT-D** This...to manufacturing, storage, handling and distribution of IGT-D finished devices , components, sub-assemblies and their compliance to regulatory… more
- AbbVie (Wyandotte, MI)
- …medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Quality Site Head is responsible for the effective operation of QA functions at the… more
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