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Experience with in vitro-in vivo novel technology feasibility assessment. Ph. D. with 5+ years of experience or MS with 10+ years of experience (Principal Scientist) or Ph. D. with 8+ years of experience or MS with 13+ years of experience (Senior Principal Scientist) , with a degree in Pharmaceutics, Biochemistry, Chemistry, Pharmaceutical Chemistry, Molecular Biology, Bioengineering, Chemical Engineering, Materials Science & Engineering or related disciplines.
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The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing and metrology, to a broad range of scientific R&D and QC measurements.
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Assists PLM's and applications with in-house (e.g., Raman Boot Camp) and outside events (e.g., workshops/seminars at customer sites) Capturing revenue through upselling and cross-selling accessories, services, contracts and more to existing customers through ServiceMax. This is to be done via cold calls, prospecting, and emails, etc.
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Experience with, or knowledge of, Water Treatment Plant Operations, EPA/DEP Regulations and International Regulatory Norm Development Procedures. Knowledge of Disinfection Byproducts (DBPs), Harmful Algal Blooms (HABs), Emerging Contaminants Issues, Petroleum and Oil Products Spills, Membrane Fouling in Advanced Water Treatment, Climate Change and NOM in Aquatic Environments, and other water contamination and monitoring issues.
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You will deliver growth by addressing market drivers and customer requirements, creating, and implementing tactical plans by working with cross-functional teams (marketing, product management, sales, life science account management, R&D), and across product lines (spectroscopy, particle, medical.
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Sell company products, including fluorescence and optical spectroscopy packages and components and potentially other spectroscopy and microscopy tools, in the assigned territory with a minimal amount of supervision.
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At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry. The Regulatory Affairs Manager will create, evaluate and execute domestic and/or international regulatory tasks related to the following: global submissions, technical file compilation, facility registrations, special projects and strategy to drive market growth worldwide.
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Collaborate with Regulatory Operations to compile and review regulatory submissions for completeness and quality. Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision.
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Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs. Job Title: Animal Facility Compliance ManagerDepartment: OperationsLocation: Immokalee, FL Job Overview: The Animal Facility Compliance Manager is responsible for ensuring the smooth operation and adherence to.
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Preferred Work Experience: At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry. Preferred Work Experience: At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry.
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Responsibilities Plans and prepares regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation) for product approvals/clearances required by the US FDA and international government agencies, including requisite pre-submissions and post-market approval reports with moderate supervision.
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A minimum of 4 years in IVD Regulatory Affairs with direct experience in preparing regulatory submissions including IDEs, 510(k)s and/or PMAs is required. Responsible for regulatory review of labels, labeling, advertising and promotional materials.
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Experience in working with medical device software requirements and companion diagnostics is a plus. Assist with logging, tracking and filing of correspondence and submissions to/from regulatory authorities and ensure that no commitment remains unduly outstanding.
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It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
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It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations.
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vitro job in New Brunswick, NJ
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