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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing regulatory documents and submissions according to Abiomed standards.
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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. Minimum of 2 years of regulatory affairs experience in the medical device industry with a track record of successful submissions.
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You will work closely with Regulatory Affairs team members and cross-functional staff members to support Regulatory programs. Job Function Regulatory Affairs. Prepare FDA submissions and other regulatory documents including 510(k)s, IDEs, Qsubs, PMA Supplements, PMA Amendments, and PMA Annual Reports.
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Have demonstrated ability to make regulatory determinations for manufacturing changes. Actively participate on project teams, review and approve protocols and reports to support regulatory submissions.
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Communicate regulatory plans and project status to internal stakeholders. Be energized by joining a world-class company and regulatory team. Must have effective regulatory writing skills.
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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. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
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Abiomed's "Patients First!" Remote work options may be considered on a case-by-case basis and if approved by the Company. Create, review and approve engineering changes and make reportability decisions per FDA guidance documents.
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Manager, Regulatory Affairs Manager - NPL/Continuous Improvement. Regulatory Affairs Manager - Drug Development. Senior Global Regulatory Affairs Manager.
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For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $88,000 to $123,000. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
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Must be able to execute tasks in a timely manner with minimal supervision. Class III Cardiovascular medical device experience. Embrace change, continuous learning, and work skills improvement. Adaptable and thrive in a dynamic work environment where variety is the routine.
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Regulatory Affairs Specialist. Regulatory Affairs Specialist. culture drives our skilled workforce and strong relationships with clinicians. Enjoy teamwork and thrive as a member of dynamic cross-functional teams.
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Review relevant guidance documents and provide interpretative assistance for new filings. Must be able to effectively work remotely. The Company maintains highly competitive, performance-based compensation programs.
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The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications. Build and maintain strong interpersonal relationships within and outside of the company.
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Must be proficient in Microsoft Office Suite, including MS Teams. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Title: manager regulatory affairs Company: Emergent Biosolutions
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