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Understands requirements for FDA Biological Product Deviations and NYS DOH Errors Incidents and Accidents reports. Participates as directed in external assessments by AABB, CAP, FDA, TJC and NYS DOH. Participates as directed in corrective action plans; preventive action planning, and quality monitoring activities.
$91,052 - $112,476 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Act as Official Correspondent to Regulatory Authorities (e.g., FDA) on behalf of Cresilon, Inc. Submit Marketing Applications to Regulatory Authorities on behalf of Cresilon, Inc. Represent Cresilon, Inc to Regulatory Authorities, both in writing and in person.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Synchron Switch ™ BCI received FDA Breakthrough Device Designation in 2020, and is currently in human clinical trials in the US and Australia. Position description: R&D Mechanical Engineering Intern – Neural Interfaces and Mechanical Systems (NIMS.
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Support engagements with regulatory authorities (e.g., FDA, EMA) on behalf of customers, across the lifecycle of drug development from pre-clinical to licensing, including contribution to briefing documents and other meeting materials, and attendance and contribution to meetings and other interactions.
RemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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As a result, we are requiring all new associates to submit proof of full vaccination with one of the three COVID-19 vaccines approved and/or authorized by the FDA, or proof of having received the first vaccine dose with the second dose scheduled, on or before their first day of employment, unless the associate has been approved for an exemption.
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In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance) HistoWiz has over 1,000 paying customers globally from top academic institutions (e.g. MSKCC, Harvard, Stanford, HHMI) and pharmaceutical companies (e.g. CRISPR, Johnson & Johnson, Regeneron.
$120,000 - $150,000 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The right candidate must be familiar with pharmaceutical or related manufacturing processes and be thoroughly familiar with GMP/cGMP regulations (e.g. FDA cGMPs, ICH, IPEC, etc. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing.
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As part of our continued efforts to maintain a safe workplace for employees and clients, and in compliance with the City of New York COVID-19 Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment.
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Familiarity with global (FDA, EMA, APAC) regulations and ICH/GCP guidelines is essential, accompanied by prior involvement in collaborative, cross-functional settings. Supervise and direct clinical trials, ensuring their timely completion within budget, and adherence to SOPs, FDA/EMA regulations, and ICH/GCP guidelines.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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3 years in quality assurance in a food manufacturing environment with strong understanding of quality assurance systems (i.e., HACCP, cGMP, FDA and/or USDA regulations, etc. 3 years in quality assurance in a food manufacturing environment with strong understanding of quality assurance systems (i.e., HACCP, cGMP, FDA and/or USDA regulations, etc.
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Comprehensive knowledge of U.S. healthcare fraud and abuse laws, FDA, OIG, FCPA, and CMS regulations, rules and guidance's, pharmaceutical marketing, price reporting, privacy, federal and state disclosure requirements.
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They will serve as a trusted expert with study / analytical KOLs, key regulatory agencies (e.g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders.
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Responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as AZ SOPs regarding safety.
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Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements.
$165,200 - $236,000 a yearFull-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Responsible for teams that oversee Duty, VAT, import/export, exposure, treated pallets, fumigation, Trade complaints, FDA, Audits. Responsible for teams that oversee Duty, VAT, import/export, exposure, treated pallets, fumigation, Trade complaints, FDA, Audits.
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fda job in Jamaica, NY
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