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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.
Full-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
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Create processes and documentation to ensure strong technical support for CRM application users, including field users, Regulatory, Legal, OEC, Medical Affairs, Operations, and others, including management of Field Help Desk knowledge base.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Collaborate and drive change with Run the Bank business owners (Front Office and Operations), Legal and Compliance, Regulatory Affairs, and the relevant Deutsche Bank technology delivery programs.
$221,500 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Lead medical affairs activities for post market surveillance. Post-market surveillance programs for regulatory bodies. This individual will help create fair and scientifically balanced materials for healthcare professionals, regulatory bodies, internal employees, and investors.
Full-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
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Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs, and quality assurance, our client enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
Full-timeExpandUpdated 25 days ago - UpvoteDownvoteShare Job
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Since being founded the team has seen phenomenal and sustained organic growth, working across Medical Affairs, Publications, Promotional, Commercial and Regulatory spaces for their roster of blue-chip pharmaceutical companies and biotech's.
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Knowledge of current TJC (The Joint Commission), CMS, CDPH, title 22, MBC, ACCME, and other regulatory standards. The Executive Director Medical Staff Affairs is responsible for the strategic and administrative direction of all medical staff services functions including credentialing, re-credentialing, medical staff bylaws and rules/regulations development and revision for the South Division.
Full-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
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Assists the Medical Staff in review and revision of Medical Staff bylaws and the rules and regulations as needed to accommodate regulatory changes and to facilitate functional improvement. Serves as a resource for and promotes compliance with regulatory standards related to all South Division medical staff offices and supports external regulatory surveys as applicable.
Full-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
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Collaborates with Regulatory Affairs as an advisor for the complaints process. Knowledge of US and international regulatory requirements pertaining to medical devices preferred. Experience writing Post Market Surveillance and Clinical Evaluation Reports.
$138,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead Design Quality Engineering on cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, R&D, Regulatory Affairs, Operations/ Planning, and Marketing.
$140,000 a yearFull-timeExpandUpdated 27 days ago - UpvoteDownvoteShare Job
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For further information about the E-Verify program, please click here:Â click hereOur Quality teams work closely with Regulatory Affairs and Engineering to ensure that the manufacturing processes outlined for each product are strictly followed and meet the appropriate FDA standards and specifications.
$185,000 a yearExpandUpdated 26 days ago - UpvoteDownvoteShare Job
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Marketing and promotion: Serve as legal reviewer alongside medical and regulatory affairs team members in the review of marketing, advertising and promotional materials. Advice and counsel: In coordination with other legal team members, provide clear and practical legal advice and risk guidance to commercial business partners and key stakeholders related to commercial activities, compliance, regulatory, and other related matters.
$200,000 depends on experienceFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. This consultant will work on international registrations and sustaining activities including but not limited to review of Change Orders, NCMR, Process Deviations, Technical File updates, and EU MDR remediation.
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Title - Regulatory Affairs Specialist II – Hybrid. Title - Regulatory Affairs Specialist II – Hybrid. Hybrid - 3 days a week Core days are Tue/Thurs with 3rd onsite day a choice. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Client products currently CE Marked under the IVD Directive.
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Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections.
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regulatory affairs jobs in Irvine, CA
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