Regulatory Affairs Specialist: Average Salary in Orange, CA in 2024

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...

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...

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...

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...

Seek guidance and feedback from higher-level authorities, such as the Specialist, Senior Specialist, Manager, Director, or Vice President of Regulatory Affairs, and other teams. The associate specialist is responsible for contributing to regulatory strategy and submission, participating in projects ...

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...

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...

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 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...

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...

Minimum two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry. ...

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...

Bachelor’s degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. ...

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...

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. ...

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...

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...

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...

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 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...

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. ...