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The Analyst II, Regulatory Affairs has experience with and performs key centralized complex and difficult regulatory activities for the Compliance Department. Knowledge of and experience with state and Federal regulatory and other requirements and practices related to Covered California, Medicare and Medi-Cal (Medicaid), Title 19 (USC)/Title 29 (USC and CCR), Title 22 (CCR), Title 28 (CCR), Title 42 (USC and CFR), CA Welfare and Institutions Code, and CA Health and Safety Code.
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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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Prior pharmaceutical industry experience and a minimum of 8 years in CMC Regulatory Affairs for Associate Director. Reporting directly to the Senior Director CMC of Regulatory Affairs, the (Associate) Director of Regulatory CMC will be responsible for the development of regulatory CMC submissions.
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It can be valuable for candidates involved in the development and submission of IVD products to regulatory agencies like the FDA. Regulatory Affairs Certification (RAC): A certification in regulatory affairs, such as the RAC from the Regulatory Affairs Professionals Society (RAPS), can be beneficial for candidates involved in FDA IVD application processes.
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The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
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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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If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
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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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Regulatory Affairs representative for the CT/AMI Systems and assists with regulatory issues related to such items as labeling and marketing ideas, claim development and prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for a program.
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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 have a minimum of a Bachelor's Degree in Regulatory Affairs, technical or science related field (Required.
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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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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 Today - UpvoteDownvoteShare Job
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Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) Regulatory affairs experience in the medical device industry with a track record of successful submissions.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Stryker
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