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. ...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
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...
A company is looking for a Global Regulatory Affairs Specialist. ...
Prior direct involvement interfacing with regulatory authorities through regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review. Principal,...
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...
Senior Regulatory Affairs Specialist - (Medical Device) - ONSITE position in. Engage with regulatory authorities and agencies to facilitate product approvals and resolve regulatory issues. If you would like to learn more about this Regulatory Affairs Specialist opportunity, apply directly or reach o...
How you will make an impact: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 t...
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 ...
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...
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...
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...
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...
Real Estate/Regulatory Specialist | Irvine, CA (Hybrid) | 30 Months Project . Managing Regulatory approval requirements and ensuring compliance with all applicable regulations. ...
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...
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...
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...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
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 ...
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...
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
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). ...