- Oracle (Washington, DC)
- …- as a reviewer and as a submitter - bringing real-world regulatory judgment to HDI's global medical device strategy cross our product portfolio. This ... Lead Regulatory Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within HDI's Regulatory & … more
- Sanofi Group (Morristown, NJ)
- …Lead in the GRA Device , General Medicine and Vaccine Medical Device and Combination Product team you'll drive global regulatory strategies for medical ... team is a globally diverse team supporting the medical device , combination product, digital health and...mission, prioritization, objectives and setting clear expectations for the device regulatory strategy , including a global… more
- Danaher Corporation (Minneapolis, MN)
- …years' experience in Project Management . + Significant experience in medical device /diagnostics regulated environment (manufacturing, R&D, supply chain, ... are a must. This position reports to the Director, Global Operations PMO and Strategy , responsible for...and all aspects of technology transfer programs/projects in the Medical Device or Diagnostics regulatory environment +… more
- Global Foundries (Essex Junction, VT)
- …specifications. This leader will work with the technology development team in setting device development strategy and driving execution of device development ... some of the world's most inspired technology companies. With a global manufacturing footprint spanning three continents, GlobalFoundries makes possible the… more
- Danaher Corporation (Chaska, MN)
- …This position reports to the Director, Strategy Development and is part of the Strategy and PMO, Global Operations and will be fully remote. In this role, ... ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate… more
- Takeda Pharmaceuticals (Lexington, MA)
- …least 5+ years of direct leadership and team management experience. + In-depth knowledge of global medical device and SaMD regulations (FDA, ISO 13485, ISO ... and drive innovation and operational excellence and execute Takeda's global Quality strategy for medical ...diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality… more
- Oracle (Augusta, ME)
- …technology strategy . You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), ... support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven… more
- L'Oreal USA (Clark, NJ)
- …/ Job Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 227067 Principal Scientist, Medical Device Expert, L'Oreal Research & Innovation ... Clark, NJ Research & Innovation Full - Time 09-Jan-2026 Principal Scientist, Medical Device Expert, Research & Innovation, Safety Evaluation, Regulatory Affairs… more
- AbbVie (North Chicago, IL)
- …Headquarters) and open to other AbbVie office locations in the US. Purpose: Medical Device Safety Physician leads the safety oversight relevant to her/his ... input to new product design teams as needed. The Medical Device Safety Physician is independently responsible... Safety Physician is independently responsible for proactive safety strategy , medical safety assessment of SAE/AEs reported… more
- Oracle (Montpelier, VT)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration with ... applications used in clinical operation, clinical information systems, and clinical decision support ( medical device and non- medical Device ). You will… more
- Merck (West Point, PA)
- **Job Description** **Senior Scientist/Engineer, Medical Device and Combination Products, Analytical** The Center for Packaging & Device Analytics (CPDA), ... support production and commercialization of product packaging and drug-delivery medical device /combination-products (MDCPs), such as auto-injectors and… more
- Oracle (Little Rock, AR)
- …Health is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product ... patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical… more
- Oracle (Helena, MT)
- …Health is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product ... patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical… more
- Sanofi Group (Morristown, NJ)
- …(GRA) Device team is a globally diverse team supporting the medical device , combination product, digital health and in-vitro diagnostic (IVD) products ... team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA...partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product… more
- AbbVie (Irvine, CA)
- …CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, ... functional areas, Operations, and Research & Development (R&D) organizations. Represents RA Device on teams such as product development, Global Regulatory… more
- Merck (Rahway, NJ)
- …for combination products and/or medical devices + Knowledge of US and global combination product/ medical device and healthcare regulations, including FDA ... This position will be responsible for leading and implementing medical device and combination product design controls...Lead the implementation and/or ensure effective execution of the device development strategy and design controls for… more
- Merck (West Point, PA)
- …development, design validation, and control strategy . + Knowledge of US and global medical device and healthcare regulations, including FDA combination ... of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and...**Principal Responsibilities:** + Lead and set direction for the device development strategy for multiple drug- device… more
- Lilly (Indianapolis, IN)
- …(SME) Oversight** : + Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support ... technical change agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance process. + Engage… more
- Lilly (Indianapolis, IN)
- …development. **Additional Preferences and Information:** + Knowledge of cGMP requirements in medical device manufacturing, highly preferred. + Experience in ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Fujifilm (Lansing, MI)
- …a combination of education and work history. + Experience in laboratory or medical device capital equipment sales or extensive experience using VisualSonics Vevo ... VisualSonics, we empower researchers to push boundaries and improve global health. As the world leader in Ultra High...analysis with customers. + Develop and execute a deal strategy . + Develop and deliver effective customer presentations. +… more