A company is looking for a Regulatory Compliance Specialist. ...
Elevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs. ...
A company is looking for a Regulatory Specialist - Dental Operations. Key Responsibilities:Support external and internal regulatory reporting, surveys, audits and investigations impacting dental operationsMonitor incoming regulations and share regulatory guidance with dental operationsPerform monito...
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
A company is looking for a Senior Regulatory Compliance Specialist. ...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications. Develop and execute r...
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. This role will involve collaborating with cross-functional teams, contrib...
As a Specialist in Premarket Regulatory Affairs, you will play a pivotal role in ensuring compliance with regulatory requirements during the early stages of product development. Act as a regulatory liaison to facilitate communication and understanding of regulatory requirements between project teams...
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 ...
Bachelor’s degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. ...
In Vitro Diagnostic Regulatory Specialist (R&D/QA). Regulatory affairs, in Quality Assurance, R&D, Manufacturing or Project Management in IVDR (Vitro Diagnostic Regulation). ...
He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Prin Regulatory Affairs Specialist. Sustaining regulatory responsibilities include reviewing changes to ensure that regulato...
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...
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...
Responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets. Regulatory Operations within the medical device industry. Understanding of US and EU medical device regulations, including submiss...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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 ...
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...
Support the EU's In Vitro Diagnosic 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...
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...
Support the EU's In Vitro Diagnosic 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 not...
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...