Regulatory Affairs Specialist: Average Salary in Santa Ana, CA in 2024

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...

Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. Regulatory Affairs Special...

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...

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...

The Regulatory Affairs Specialist is responsible for assembling CE Technical files and final review of deliverables for MDR regulatory compliance. Prepares monthly reports on status of current issues to the Manager of Regulatory Affairs. Review regulatory publications to keep apprised of new regulat...

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 ...

Immediate opportunity for a Regulatory Affairs Specialist II with a leading, global eye care company located in Lake Forest, CA. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of su...

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...

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...

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...

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...

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...

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 ...

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...

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...

Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections). Prepare and submit product registrations and submissi...

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 ...

Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company-Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced-Technical wri...

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 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...