A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps. ...
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices. ...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Ability to interpret and apply regulatory requirements....
A company is looking for a Regulatory Affairs Specialist responsible for managing regulatory activities related to the Lung Health product portfolio. ...
We create products lines that include vegan skincare, cosmetics, and nutrition and have an immediate opportunity for a Regulatory Affairs professional with a background in Nutrition to join our team. The position of Regulatory Specialist I in Nutrition reports to the Sr. Provide timely responses to ...
Regulatory Affairs Specialist II. On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directiv...
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. ...
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
Hybrid - 3 days a week Core days are Tue/Thurs with 3rd onsite day a choice.Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Client products currently CE Marked under the IVD Directive.Activities include preparation revision of technical files when ne...
Minimum of 10 years of regulatory affairs experience or advanced degree with a minimum of 8 years of experience. Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new product development projects. Reviews Regulatory Strategies/...
Senior Principal Regulatory Affairs Specialist - Remote. Minimum of 10 years of regulatory affairs experience or advanced degree with a minimum of 8 years of experience. Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new pro...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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 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...
Regulatory Affairs Specialist II. On behalf of our client a Medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under ...
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...
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...
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:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
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...
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
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...