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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.
$51,824 - $63,600 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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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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Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California page is loaded. Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California.
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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 Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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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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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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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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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. Abiomed's "Patients First.
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Remote work options may be considered on a case-by-case basis and if approved by the Company. Ability to comprehend principles of engineering, physiology and medical device use. Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA.
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Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
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For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results.
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regulatory affairs jobs Title: regulatory affairs manager Company: Johnson
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