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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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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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Experience working with govt affairs, and other trade and regulatory bodies within Cisco and external to Cisco. Represent global manufacturing operations and supply chain in multidisciplinary govt affairs and trade team conversations where applicable.
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You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination products from preclinical candidate designation through product approval, including regulatory submissions.
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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. 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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We are currently seeking a Senior Regulatory Compliance Specialist to join our Endoscopy Division to be based in San Jose, CA, Flower Mound, TX, Denver, CO or remote. What you will doAs the Regulatory Compliance Specialist, you will be responsible for planning, coordination, and execution of post market regulatory compliance activities, such as field actions assessments, commercial holds, and recalls, in addition to leading continuous improvement initiatives.
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Experience: Minimum of 3 years of experience in regulatory affairs. Industry: Prior regulatory experience in the medical device, food, dietary supplement, or pharmaceutical industry preferred.
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12+ years of work experience in a highly regulated industry as a regulatory affairs professional (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences) Reality Labs is seeking an experienced medical devices regulatory affairs professional to lead the regulatory strategy and product approvals for novel hardware and software as a medical device products for distribution into many worldwide markets.
$281,000 a yearExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year 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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Work cross functionally with different departments including R&D Engineering, Supplier Quality, Marketing, and Clinical Affairs to assist in regulatory decision-making and develop a broad understanding of the medical device industry.
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8+ years relevant experience in quality control, quality assurance, and regulatory affairs at a Class I or Class II medical device manufacturer. Coordinate and organize test data and clinical or scientific reviews in support of regulatory submissions.
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Understanding of Regulatory Affairs concepts and regulations/guidelines governing the development of IVD diagnostic products. The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle management project teams.
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The Regulatory Affairs Senior Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for Cepheid’s in vitro diagnostic products. Senior Regulatory Affairs Specialist I.
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Advanced degree such as MS or PhD in scientific/bioengineering field with 8-12 years of experience in Regulatory Affairs. The purpose of the Director of Regulatory Affairs, Imaging Agent Drug Development is to lead cross functional teams in major regulatory submissions to the Center for Drug Evaluation and Research (CDER), inclusive of New Drug Applications (NDA), End of Phase (EOP) Type B meetings, health authority interactions, label discussions, and securing approvals as part of an effort to bring small molecule fluorescence imaging agents to market.
$312,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
affairs job Title: regulatory in Milpitas, CA
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