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Requires Masters degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and six years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs, or a Bachelors degree in Regulatory Affairs, Biomedical Engineering, or Medical Device Engineering, and eight years of experience as a Regulatory Affairs Manager or Regulatory Affairs Specialist or related occupation in regulatory affairs.
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We are seeking a driven, creative, collaborative, and highly respected individual who is passionate about public policy, government affairs, regulatory policy, helping patients, innovative science, biotechnology, and public health to serve as Vice President, Policy & Advocacy.
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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We believe that our PCVs could receive regulatory approval based on successful completion of clinical studies utilizing well-defined surrogate immune endpoints, consistent with how other PCVs have obtained regulatory approval in the past, rather than requiring clinical field efficacy studies.
$144,000 - $162,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
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Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. Responsibilities include working with the research team and clinical staff to support clinical trial conduct, maintaining regulatory compliance, and providing general communication with both internal and external stakeholders.
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Ensure compliance with industry standards and regulatory requirements (e.g., PCI-DSS, GDPR) We are looking for a highly technical Sr. Network Engineer who can lead people and projects to join our driven NetOps team.
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A law firm in Palo Alto, CA is seeking a Junior Digital Health Associate Attorney with 2-4 years of experience in healthcare law and regulatory compliance. Provide comprehensive legal counsel to digital health clients on regulatory compliance issues, including HIPAA, Anti-Kickback Statute, Stark Law, and False Claims Act.
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The Director/Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum’s gene therapy program/s. Manage the Regulatory Affairs (CMC) Strategy for Regulatory Affairs.
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
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Ensure that each group has appropriate protocols to support tech transfer including process development, QA/QC, and regulatory. Experience interacting with government regulatory agencies is a plus (FDA, DEA, etc.
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As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Consistently ranked as number one in the space, NICE Actimize experts apply innovative technology to protect institutions and safeguard consumers and investors assets by identifying financial crime, preventing fraud and providing regulatory compliance.
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Associate Director, Analytical Development, Raw Materials. Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions.
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regulatory job Title: sr regulatory affairs associate Company: Thermo Fisher Scientific in Palo Alto, CA
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