Regulatory Affairs Specialist II. Participate in review and implementation of new and/or revised external regulatory standards and approval of marketing materials. Advance degree and/or Regulatory Affairs Certification are a plus. ...
Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accura...
Our client, a large healthcare company is seeking a Regulatory Affairs Specialist to join their team! As the Regulatory Affairs Specialist you would provide regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensu...
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products. Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including pre...
This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. Provides guidance on regulatory requirements necessary for strategic an...
This role reports directly to the Vice President who is a great mentor and looking to help someone learn and build their expertise in the medical device regulatory landscape. Supervising and coordinating submissions for international product registration, monitoring the progress of internal regional...
BRTitle:Specialist I, Regulatory AffairsJob Description:This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the ...
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...
Regulatory Affairs Specialist II. Participate in review and implementation of new and/or revised external regulatory standards and approval of marketing materials. Advance degree and/or Regulatory Affairs Certification are a plus. ...
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...
Seeking a Regulatory Affairs Specialist to manage updates and compliance for technical files and labeling under the new IVDR requirements, ensuring seamless transition from IVD Directive. Regulatory Affairs (RA), Quality Assurance (QA), Research and Development (R&D), Manufacturing, or Project Manag...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training progra...
The Regulatory Affairs Specialist III, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U. The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new p...
As a Senior Specialist, International Regulatory Affairs, you complete and maintain regulatory approvals and clearances of assigned products. Representing the OUS regulatory function on manufacturing and product development teams to providing input on regulatory requirements, including presenting al...
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...
Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market, provide advice on regulatory requirements and prepare regulatory submissions. Maintain Regulatory Affairs product files to support compliance with regulatory requirem...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and rep...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Regulatory Affairs Specialist II. Participate in review and implementation of new and/or revised external regulatory standards and approval of marketing materials. Advance degree and/or Regulatory Affairs Certification are a plus. ...
Real Estate/Regulatory Specialist | Irvine, CA (Hybrid) | 30 Months Project . Managing Regulatory approval requirements and ensuring compliance with all applicable regulations. ...
The Regulatory Affairs Specialist III, will provide administrative and technical support to regulatory affairs leadership in order to facilitate compliance with U. The Regulatory Affairs Specialist provides direct Worldwide Regulatory support to lifecycle management and new product development/new p...
In Vitro Diagnostic Regulatory Specialist (R&D/QA). Regulatory affairs, in Quality Assurance, R&D, Manufacturing or Project Management in IVDR (Vitro Diagnostic Regulation). ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...