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...

Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

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...

Are you passionate about navigating global regulatory landscapes and ensuring the compliance of life-saving medical devices? We're looking for a skilled Regulatory Affairs Specialist to join a vibrant team in Irvine, CA! This medical device company are pioneering innovative medical solutions that enhance patient care worldwide. Their International...

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...

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...

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

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...