A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products. CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required. ...
Seniro Regulatory Affairs Specialist. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regul...
As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Exercise judgme...
Title: Regulatory Affairs Specialist - Contractor. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare responses to customer requests for information...
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 ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Exercise judgme...
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 ...
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional n...
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. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
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...
The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for SkinMedica products. With supervision, the specialist reviews, plans and prepares regulatory documents and labelling for cosmetic or OTC product registrations/updates. With supervision...
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...
He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Minimum of 7 years of experience medical device regulatory affairs Or advanced degree with a minimum of 5 years of experienc...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currenlty CE Marked under the IVD Directive.Activites include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional no...
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...
Seeking a Senior Regulatory Affairs Specialist with expertise in US and EU regulatory requirements, EU MDR regulation, and medical device regulatory submissions to sustain the current product portfolio. Partner with the international regulatory affairs group to support regulatory submissions. In-dep...
Thorough knowledge of policies, practices and procedures related to Regulatory Affairs. Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the IVD industry. ...
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...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance. Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved ...
Regulatory Notifications</b>:</p> <ul> <li>Update the technical file tracking log and track regional regulatory notifications of labeling changes. Regulatory Affairs, Biomedical Engineering, or Life Sciences). Miscellaneous Tasks</b>:</p> <ul> <li>Comp...
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 ...
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 ...