Regulatory Affairs Specialist

Senior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the...

Senior Specialist, Regulatory Affairs, Critical Care Company: Edwards Lifesciences LLC Position: Req-33420 Location: Irvine, CA Posted: May 13, 2024 Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory...

Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months . The consultant will need to work onsite at least 3 days/week . The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

Regulatory Affairs ConsultantIrvine, CAA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special 510k...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

· 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

Job DescriptionJob DescriptionSummary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.Key Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and...

Overview: MedAlliance is a leading and innovative combination medical device company dedicated to improving patient outcomes and enhancing healthcare worldwide. We specialize in the development, manufacturing, and commercialization of cutting-edge coronary and peripheral medical devices that integrate pharmaceuticals with traditional medical devices. Our...

Job Description Purpose: AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence...

Job Description   Description     The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing...

Job Description The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx...

Job Title: Regulatory Affairs Specialist Job Responsibilities: This position is responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with FDA regulations, ISO standards, and other regulatory agencies. General Description and Duties: To perform this job...

Job Description:Pay Range $44.60hr - $49.60hrResponsibilities:Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy.Participate in providing guidance on strategies and...

Job Description: Pay Range $44.60hr - $49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy. Participate in providing guidance on strategies and...