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Provide hands-on Support to the Logistics Specialist in preparing Hardware for Clinical Trials (e.g. App Setup, Connecting Devices, Labeling, Boxing)Ownership of Mobile Device Management (MDM) including Device Assignment, MDM Configuration, Version control etc.
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We’re seeking a Regulatory Affairs - Specialist Global Labeling Lead Medical Devices to work at a premier medical device company in Rochester, NY. With us, it’s all about finding the job that’s just right.
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Primary Talent Partners has a 12 month contract opening for a Regulatory Affairs Specialist (MDR) with a Medical Device client of ours. Provide support to transition currently marketed products from EU MDD to EU MDR, including review of product/ manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling.
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Resource Label provides products and services for the food, beverage, chemical, household products, personal care, nutraceutical, pharmaceutical, medical device, and technology industries. This role is responsible for packaging and preparation for shipping all converted products which includes labeling, boxing, packing list's and the wrapping of skids.
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The In-Vitro Diagnostic portfolio provides the golden standard of molecular based immunoassay technology for liver surveillance, cutting edge clinical diagnostic chemicals for leading laboratories across the country and diagnostic chemicals for OEM white labeling products.
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Assures a sufficient supply of radiopharmaceuticals in accordance with licensing possession limits, maintaining records of identification and labeling of all radiopharmaceutical preparations. Obtains field uniformity images and spatial resolution checks of gamma camera for non-uniformity and degradation of resolution and assures integrity of photographic recording device.
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Be responsible for required device and accessory product change submissions - FDA and EU MDR, EU Cert Renewals, e-Labeling, along with required product release approvals (PRA). This device system portfolio includes class III and class II devices, along with related system accessories, for US, EU, APAC, LATAM, CA, AUS.NZ and other geographies.
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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions, including labeling review.
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Possess clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
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You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.
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4 YOE in pharmaceutical packaging. Bachelor’s degree in Packaging, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field and 2 years of engineering/scientific experience OR.
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Pharmacy automation, involving robotics and automated systems, plays a vital role in dispensing, packaging, labeling, and organizing medications with precision and efficiency. We are currently seeking a Senior Quality Engineer to contribute to a project that enhances pharmacy performance and device uptime through real-time analytics and detailed reporting.
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Assembly activities include but are not limited to Crimping, Cutting, Soldering, Heat shrinking, Heat stamping, Ultrasonic Welding, Solvent Bonding - Tubing, UV epoxy dispensing, Hi Pot testing, continuity testing, Pressure testing, Coiling/Wrapping, Sealing - Pouch, Band, Tray, Boxing/Labeling, In Process Inspection - visual, microscope, and final, Packaging of Final Product.
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The Manufacturing Technician I learns and performs a variety of tasks with supervision and in accordance with the manufacturing instruction set inclusive of current GMP/ISO requirement and standards and following all safety guidelines of PCI. With supervision, the technician performs routine and critical manufacturing operations, including but not limited to work functions in equipment prep, formulation, aseptic compounding, and filling activities for biopharma and medical device products.
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