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QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
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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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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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Preferred Work Experience: 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. 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.
$1 - $2 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Identify and draft necessary SOPs and/or Working Practices for Regulatory Affairs Qualifications Minimum of Bachelor’s degree. 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.
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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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Responsible for regulatory review of labels, labeling, advertising and promotional materials. 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.
$1 - $2 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Ensures regulatory submissions are prepared and processed in a proactive and timely mannerEvaluates proposed changes for regulatory impact with minimal supervision. requiredProject and team management skills – required (Company Management System skills – preferred)Analytical and problem-solving skills – requiredComputer skills, including standard business software tools and typing – requiredAble to function in a matrix organization—desiredMulti-tasking skills—desiredFlexibility to meet continuously changing priorities and challengesSupervisory or project team leadership experience is desired.
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Ability to effectively translate regulatory requirements into practical advice to cross-functional teams and other audiences. Demonstrated PC experience with SPCXL, MS Word, Excel and PowerPoint Knowledge:US and EU regulatory submission requirements.
$1 - $2 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry. At least three years of experience working in regulatory affairs roles on CDx projects within the in vitro diagnostic industry.
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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.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Maintains an open line of communication with supervisors and manufacturing management regarding shortages and delays. Maintains an open line of communication with suppliers to ensure on-time delivery.
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Additionally, this individual will provide leadership and guidance to the Regulatory team on regulatory matters. Skills: Able to effect Quality Improvement through problem solving skills and knowledge of quality tools – requiredAble to lead and drive change – requiredOrganization skills.
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Excellent oral and written communication skills, including the ability to discuss regulatory strategy and requirements with senior management. Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams.
$1 - $2ExpandApply NowActive JobUpdated 6 days ago
vitro job in Piscataway, NJ
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