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A minimum of 6-10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulatio ns, product stewardship and industrial risk management in the medical device or manufacturing industries.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug discovery and development, cell and molecular biology, genetics, biochemistry, microbiology, laboratory instruction, biotechnology finance, regulatory affairs, clinical trials, project management, or manufacturing.
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Basic understanding of regulatory affairs concepts, guidelines, and regulations governing the development, documentation, and labeling of in vitro diagnostic products. Kelly® Science & Clinical is currently recruiting for a Technical Writer for a 6-month contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
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This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division. 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
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This role will partner with Clinical Affairs, Medical Affairs, Regulatory, Business Development, Product Development and other cross-functional teams to establish and execute short- and long-term GAVE strategic plans.
$261,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience focused on quality systems, regulatory affairs/compliance or project management. ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus. Overview: Responsible for supporting development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and corporate requirements.
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Bachelor's degree in Public Policy, Regulatory Affairs, Environmental Science, or a related field (Master's/MBA preferred). Demonstrated success in a regulatory affairs, public policy, or related role.
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Minimum of 5 years of experience in CRMS/MA (e.g. medical science, clinical, affairs, regulatory affairs and/or healthcare economics) within the medical device or pharmaceutical industry with a Bachelor's degree, or 3 years with an advanced degree.
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Experience in international and/or regional Product Safety, Environmental, EMC, and Regulatory standards/regulations, and/or government affairs is a plus. We lead within the worldwide operations team and collaborate across engineering, software, regulatory, and other teams to create impact through novel and significant projects.
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Collaborate closely with Clinical Operations, Quality Assurance, CMC, and Regulatory Affairs to ensure compliant and timely delivery of clinical supplies. Lead clinical supply activities for ongoing and new trials, including demand forecasting, trial monitoring, resupply planning, label design, and IRT setup.
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Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Responsibilities: Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
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Founded in 1999 , Mindlance has been ranked as one of the fastest growing US Staffing firms by SIA for 9 consecutive years.
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Kelly® Science & Clinical is seeking two experienced Technical Writers for a 6-month contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.
$50 an hourExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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This is Vydehi from Intellectt Inc. We currently have an opening for a Regulatory affairs Project Manager with one of our medical device clients. Regulatory operations: BUDI number updates, label reviews, FDA laser report, state manufacturing license etc.
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regulatory affairs jobs in San Jose, CA
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