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The Lynn Public Schools is currently seeking an energetic and financially detail-oriented individual for the position of Director of State, Federal, Foundation Grants and Regulatory Compliance.
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Patients First | Innovation | Winning Culture | Heart Recovery POSITION SUMMARY Our Regulatory Affairs team supports Abiomed in navigating complex regulatory landscapes to bring the latest innovations in heart recovery to our patients.
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Amazon Robotics is seeking an EMC Test Technician to fill a position having an emphasis on performing in-house accredited regulatory compliance laboratory testing. The candidate will have a strong understanding of regulatory compliance schemes, and the process required to specify, test, qualify, document, and maintain certifications related to Electromagnetic Compatibility (EMC) compliance for domestic and international markets; and places a high value on accuracy/precision, is a good multi-tasker, follows directions well, effectively communicates status, and consistently exercises good judgement.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Manager, located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
$170,000 a yearPart-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Knowledge: Strong understanding of FDA regulations, ISO standards, and other relevant regulatory requirements such as cGMP/Quality System Regulations (QSR), International Standards for Organization (ISO), Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (2017/745.
$185,000 a yearFull-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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This position is hybrid, based in Santa Monica, CA, and reports to the Executive Director, CMC Regulatory Affairs. The AD CMC Regulatory Affairs supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early-stage T cell therapies.
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The Regulatory Affairs and Quality Assurance Associate shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, and support in all chosen distribution markets.
$70,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Ensure that all products and processes comply with applicable regulatory requirements (e.g., FDA, EU MDR, ISO). Regulatory Affairs Certification (RAC) or equivalent preferred. Prepare and submit regulatory documentation and applications, including product registrations, certifications, and renewals.
$190,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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The C+AI Trusted Platform Legal Team provides direct support to the C+AI Trusted Platform compliance engineering team, which drives legal and regulatory compliance programs, initiatives, and requirements across the enterprise products and services in the C+AI business division at Microsoft, including Azure, Dynamics 365, and Power Platform.
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The Regulatory Affairs Manager will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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Experience with global regulatory requirements and guidelines (including FDA, EMA, IHC), from preclinical and clinical stages. Manage third-party vendor partner performance and workload to support regulatory operations and regulatory publishing.
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This position leads efforts to ensure continuous organizational compliance and ongoing survey readiness with clinical quality and patient safety standards and regulations required by The Joint Commission (TJC), Massachusetts Department of Public Health (DPH), Center for Medicare and Medicaid Services (CMS) and other regulatory agencies as needed.
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