Current jobs related to Regulatory Affairs - Palo Alto - The Judge Group
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Regulatory Affairs Specialist
1 week ago
Palo Alto, California, United States Recor Medical Inc. Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Recor Medical Inc. as a Staff/Principal Regulatory Affairs Specialist. This is a critical role that will contribute to the development of regulatory strategies, prepare submissions, and obtain approval for our product portfolio.Key ResponsibilitiesRegulatory...
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Senior Regulatory Affairs Expert
3 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. With our innovative Paradise uRDN System, we strive to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage...
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Senior Regulatory Affairs Specialist
2 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. Our innovative Paradise uRDN System is designed to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive method to manage their blood pressure...
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Senior Regulatory Affairs Specialist
2 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. Our innovative Paradise uRDN System is designed to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage their...
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Senior Regulatory Affairs Specialist
2 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. Our innovative Paradise uRDN System is designed to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage their...
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Senior Regulatory Affairs Expert
2 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. With our innovative Paradise uRDN System, we strive to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage...
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Senior Regulatory Affairs Expert
2 weeks ago
Palo Alto, California, United States Recor Medical Inc. Full timeAt Recor Medical, we are at the forefront of developing Ultrasound Renal Denervation (uRDN) therapy aimed at addressing hypertension, a significant cardiovascular risk factor globally. With our innovative Paradise uRDN System, we strive to offer millions suffering from hypertension a non-pharmaceutical and minimally invasive solution to effectively manage...
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Palo Alto, California, United States Stanford Blood Center Full timeJob SummaryThe Stanford Blood Center is seeking a highly skilled and experienced Director of Academic Affairs and Strategic Operations to join our team. This is a dynamic and challenging role that requires a strong leader with a proven track record of success in academic affairs and human resources.Key ResponsibilitiesProvide strategic direction and...
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Palo Alto, California, United States Stanford University Full timeJob SummaryWe are seeking a highly experienced and strategic leader to serve as the Director of Academic Affairs and HR Strategies at Stanford University. The successful candidate will provide visionary leadership and oversight for Academic Affairs and Human Resources, driving strategic initiatives and ensuring seamless execution of departmental goals.Key...
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Palo Alto, California, United States Stanford University Full timeSenior University Counsel, Student and Academic AffairsStanford University is seeking a highly experienced and skilled Senior University Counsel to join its Office of the General Counsel. This is a full-time position that reports to the Deputy General Counsel and Managing Attorney.About the RoleProvide strategic legal advice on student and academic affairs...
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Diagnostic Radiologic Technologist
5 hours ago
Palo Alto, California, United States Veterans Affairs, Veterans Health Administration Full timeAbout the RoleWe are seeking a highly skilled Diagnostic Radiologic Technologist to join our team at the Veterans Affairs, Veterans Health Administration. As a key member of our imaging department, you will be responsible for performing complex imaging procedures, including mammography, general radiology, and other modalities as needed.Key...
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Palo Alto, California, United States Guardant Health Full timeJob SummaryGuardant Health is a leading precision oncology company dedicated to helping conquer cancer globally through the use of its proprietary tests, vast data sets, and advanced analytics. The company's oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages...
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Equal Employment Manager
2 months ago
Palo Alto, California, United States Veterans Affairs, Veterans Health Administration Full timeSummary The Equal Employment Manager serves as a senior level manager responsible for the Equal Employment Opportunity/Affirmative Employment (EEO/AE), EEO case Alternative Dispute Resolution (ADR), and external Civil Rights (CR) functions in a major organization within the Department of Veterans Affairs (VA), VA Palo Alto Health Care System (VAPAHCS)....
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Palo Alto, California, United States Guardant Health Full timeJob SummaryWe are seeking a highly experienced Senior Director to lead our global publication strategy for our oncology genomics portfolio at Guardant Health. As a key member of our Medical Affairs team, you will be responsible for developing and executing a comprehensive publication strategy to support our business objectives and regulatory requirements.Key...
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Supervisory Health System Specialist
4 weeks ago
Palo Alto, California, United States Veterans Affairs, Veterans Health Administration Full timeSummary The incumbent serves as a Supervisory Health System Specialist - Whole Health Program Manager. The Whole Health Program Manager is responsible for the overall planning, development, and coordination, of a comprehensive and complex Whole Health System, including all list one modalities offered in the Whole Health System.DIRECT HIRE AUTHORITY:This...
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Head of External Affairs
2 weeks ago
Palo Alto, California, United States Guardant Health Full timeJob DescriptionGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through the use of its proprietary tests, vast data sets, and advanced analytics. The company's oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes, and lower healthcare costs across all stages...
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Registered Nurse
2 months ago
Palo Alto, California, United States Veterans Affairs, Veterans Health Administration Full timeSummary The SIPS Nurse Educator is responsible for assessing, planning, implementing, and evaluating the educational activities and programs for nursing service staff within the VAPA HCS. Works collaboratively and consults with management and multidisciplinary teams to develop, implement, and evaluate educational programs for staff, maintain and enhance...
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ECT Program Coordinator
2 weeks ago
Palo Alto, California, United States Stanford Health Care Full timeJob SummaryWe are seeking a highly skilled and compassionate ECT Program Coordinator to join our team at Stanford Health Care. This is a critical role that requires strong clinical knowledge, excellent communication skills, and the ability to work effectively in a fast-paced environment.Key ResponsibilitiesCare Coordination: Provide comprehensive care...
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Project Manager- Life Sciences
1 month ago
Palo Alto, United States Incedo Inc. Full timeJob Description: We are seeking a highly skilled and motivated Project Manager to join our Life Sciences team. The ideal candidate will have a strong background in life sciences, project management, and a passion for delivering projects that make a difference in the healthcare and biotechnological sectors. You will be responsible for overseeing the planning,...
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Project Manager- Life Sciences
1 month ago
Palo Alto, United States Incedo Inc. Full timeJob Description: We are seeking a highly skilled and motivated Project Manager to join our Life Sciences team. The ideal candidate will have a strong background in life sciences, project management, and a passion for delivering projects that make a difference in the healthcare and biotechnological sectors. You will be responsible for overseeing the planning,...
Regulatory Affairs
3 months ago
Our client is currently seeking a Regulatory Affairs for a 12 month + contract.Hybrid position, 2 days in office (Palo Alto, CA).Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements* Identifies, analyzes and implements country specific requirements necessary for product related submissions. *Recommend strategies for earliest possible approvals for marketing applications * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentation/information to local authorities or internal. * Initiates and escalates necessary activities if deviations are identified. * Ensures creation of adequate documentation for audits/inspections. * Performs training within the organization in country specific regulatory requirements, if applicable. *Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance. * Performs review of promotional material for regulatory compliance according to country specific requirements.
Impacts: Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.Experience: 5-8 years.Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files. Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices). Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standardTeamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.
