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...

Job Title: Regulatory Affairs Specialist Location: Irvine, CA Schedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/Thur Duration: 1 year with potential to extend/ convert to internal FTE no fully remote option hourly rate of $40-45/hr About Us: We are seeking a Regulatory Affairs Specialist to join our team in Irvine, CA. Our company...

Job Title: Regulatory Affairs SpecialistLocation: Irvine, CASchedule: Hybrid, Monday to Friday, 8 AM to 5 PM, with on-site work Tue/ThurDuration: 1 year with potential to extend/ convert to internal FTEno fully remote optionhourly rate of $40-45/hrAbout Us: We are seeking a Regulatory Affairs Specialist to join our team in Irvine, CA. Our company focuses on...

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...

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...

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 510k regulatory submission with a deadline...

Job Description: 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 document milestone...

Job Description: 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 document milestone...

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...

For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because were committed to creating a world whe Regulatory Affairs, International, Regulatory, Critical Care, Specialist, Product Development, Manufacturing,...