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Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Collaborate with cross-functional teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and tox) to meet CMC and program goals.
$118 an hourFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Knowledge and understanding of regulatory reporting requirements for medical devices (US FDA requirements, EU MDD requirements, etc.) Our Client, the pioneer of and global technology leader in robotic-assisted surgery has a Regulatory Post Market Surveillance opening in Sunnyvale, CA.
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The ideal candidate will have substantial law firm experience representing biotechs and big pharmas as they license patents and collaborate to advance novel therapeutics, vaccines, diagnostic and digital health technologies through clinical trials and toward regulatory (FDA) approval.
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Demonstrates commitment to the development, implementation and effectiveness of ARDx Informatics’ Quality Management System per ISO, FDA and other regulatory agencies. The Opportunity The Informatics Business Development Rep is a point-of-care software sales professional that’s highly skilled at driving exponential growth in their territory through closing new business and expanding existing business space.
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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. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
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Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) regulations. This position is responsible for performing material movements, generating work orders, and maintaining a safe and organized work environment while supporting company initiatives and regulatory requirements.
ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Ensure compliance with regulatory standards (e.g., FDA, ISO) and biohazard safety requirements. Understanding of regulatory and compliance requirements for IVD products (e.g., QSR, ISO, GLP.
$70 an hourFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Knowledge and experience managing compliance with global product regulatory regimes, such as: FDA, Health Canada, European Union REACH, Good Manufacturing Practices (GMP), Global Harmonization System (GHS), Classification for Labelling & Packaging (CLP), Hazard Communication, Hazard Analysis & Critical Control Point (HACCP), Toxic Substances Control Act (TSCA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and/or emerging corporate sustainability regulations.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Establish, implement, and maintain company quality systems in compliance with FDA, International Standards (ISO), and other regulatory agencies. Review and approval all lot history records and sterile load records to ensure product compliance with specifications and regulatory requirements.
$220,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Lead external audits, including those from customers, notified bodies, FDA, and other regulatory authorities, and successfully address/close all findings, particularly for medical products.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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At least 5 years of experience in the medical device IVD industry, with a strong understanding of FDA regulatory standards and compliance requirements. Demonstrated experience with AWS services (e.g., EC2, RDS, S3, Lambda, Glue, Redshift, Athena, EMR) and data pipeline tools (e.g., Apache Airflow, Luigi, etc.
$178,400 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Responsible for establishing and maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD)/European Union Medical Device Regulation (MDR) as well as all other applicable global regulatory requirements.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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We are currently seeking a Senior Staff Regulatory Affairs Specialist to join our Endoscopy division based hybrid on-site three days per week in San Jose, CA. As the Senior Staff Regulatory Affairs Specialist , you will play an integral role on our Open Field Visualization premarket regulatory team, specifically supporting business development activities, actively participating in the integration of Regulatory roles and responsibilities for newly acquired technology MOLLI Surgical.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Good understanding of submission for FDA and MDR. This person will definitely have knowledge of QMS (Able to support CAPA documents and audits when they come, and able to understand what documents will be required for audits and prepare them.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Global Quality and Regulatory Affairs (GQRA) Field Action Specialist’s responsibilities include managing Field Action Activities such as: leading Field Action Strategy and Field Safety Communication meetings, recalls, field notifications and correction processes for medical and non-medical products.
Full-timeExpandApply NowActive JobUpdated 12 days ago
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