Regulatory Affairs Consultant

1 month ago


Irvine, United States Redbock - an NES Fircroft company Full time

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 510k regulatory submission with a deadline of early July 2024. The Regulatory team is currently only 3 people so this consultant will need to work mostly independently to create the 510k submission. This consultant may also be involved in the review of test protocols in coordination with the R&D and Quality teams.

Top Requirements:

  • BS degree minimum
  • 5+ years of Medical Device industry experience as a Regulatory Affairs specialist
  • Orthopedics device experience is a plus
  • Experience with devices that have software components is a plus
  • Able to independently develop a 510k submission, requires strong knowledge of all components/sections that go into this submission
  • Experience with Special or Abbreviated 510k submissions
  • Strong communication skills, able to collaborate effectively with cross-functional teams



  • Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    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...


  • Irvine, Kentucky, United States AbbVie Full time

    Company DescriptionAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a...


  • Irvine, United States Edwards Lifesciences Full time

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...


  • Irvine, United States Allergan Aesthetics Full time

    **Company Description** Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning for assigned on market products or those products in development for Aesthetics-Pharma. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and...


  • Irvine, United States OrthAlign Full time

    OrthAlign, Inc. , a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. In this role,...


  • Irvine, United States OrthAlign Full time

    Job Description Job Description Salary: $100k + DOE OrthAlign, Inc. , a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory...


  • Irvine, United States OrthAlign Full time

    OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance of all new and existing products. In this role,...


  • Irvine, United States OrthAlign Inc. Full time

    Job DescriptionJob DescriptionSalary: $100k + DOEOrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance...


  • Irvine, United States OrthAlign Inc. Full time

    Job DescriptionJob DescriptionSalary: $100k + DOEOrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Senior Regulatory Affairs Specialist responsible for implementing regulatory strategies, assisting with the preparation, organization, and maintenance of documentation sufficient to ensure regulatory compliance...


  • Irvine, United States Cypress HCM Full time

    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 customer...


  • Irvine, United States Cypress HCM Full time

    · 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...


  • Irvine, United States Cypress HCM Full time

    · 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...


  • Irvine, United States Cypress HCM Full time

    · 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...


  • Irvine, United States Cypress HCM Full time

    · 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...


  • Irvine, United States Cypress HCM Full time

    · 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...


  • Irvine, United States AbbVie Full time

    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 in our...


  • Irvine, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...


  • Irvine, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...


  • Irvine, United States NeuroVasc Technologies, Inc. Full time

    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...


  • Irvine, United States Allergan Aesthetics Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie'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...