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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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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 is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
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Senior Regulatory Affairs Specialist. 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.
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Become a Regulatory Affairs Infrastructure Licensing Advisor at Southern California Edison (SCE) and build a better tomorrow. As a Regulatory Affairs Infrastructure Licensing Advisor, your work will help bring to fruition the transmission and other major projects that will help power our planet, reduce carbon emissions and create cleaner air for everyone.
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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical products. Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required.
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In this role, the Market and Regulatory Affairs Lead will participate as a stakeholder in RTO/ISO stakeholder processes, serve as the liaison for trade groups and collaborate with industry stakeholders to address issues that are relevant to LRE interests throughout the country.
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The Market and Regulatory Affairs Lead must possess strong communication skills and will work with departments across the company to convey changes and the anticipated impact on LRE business.
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To do these effectively, the Analyst III – Policy & Regulatory Operations must have a demonstrated understanding of IEHP business operations and responsibilities of various departments in Health Services, Quality Systems, Provider Services, and Member Services; subject matter expertise of these departments’ policies and procedures and the regulations that drive their business operations and demonstrated ability to effectively and consistently manage multiple projects and priorities concurrently.
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Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing - CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes.
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Internal stakeholders include Brand Marketing, Commercial Development, Regulatory, Sales, Corporate Accounts, Sales Training, Field Reimbursement Support, Pricing, Contracting, Patient Services, Government Affairs, and HEOR. Ensures that field-based professionals (Corporate Account Managers, Sales Representatives) are aligned with HCS-led initiatives.
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Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Provide CMC regulatory review for clinical protocols and investigator brochures, etc.
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Supports the Director, Regulatory Law, Government Affairs and Trade Compliance in managing risk within the defined scope of responsibility. Reports to: Director, Regulatory Law, Government Affairs and Trade Compliance.
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regulatory affairs jobs Title: sr director Company: Csl Behring
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