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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Director/Sr. Director, CMC Regulatory Affairs is responsible for development and lead of the CMC regulatory strategy for early-stage T-cell therapies. Represent CMC regulatory affairs on product teams and in health authority interactions.
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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist 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.
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The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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Senior Regulatory Affairs Specialist. Regulatory affairs experience in the medical device industry with a track record of successful submissions. Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.
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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You've acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K's, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
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Reporting to the SVP, Government Affairs, the VP Government Affairs is responsible for planning, overseeing, and directing the government affairs function for Baylor Scott and White Health (BSWH), which may include federal, state, and local government affairs, policy research, policy advocacy programs, and other regulatory oversight activities that impact BSWH healthcare operations.
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Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings.
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Provide ongoing support to project teams for regulatory issues and questions. Interact and negotiate with regulatory agencies on defined matters as needed. Assist in the maintenance and improvement of regulatory SOPs.
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Be energized by joining a world-class company and regulatory team. Strong communication and regulatory writing skills. Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
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Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Abiomed's "Patients First!" Remote work options may be considered on a case-by-case basis and if approved by the Company.
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regulatory affairs jobs Title: affairs specialist Company: Sanofi
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