Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Global Regulatory Affairs Specialist II - Medical Devices

Masimo Wearables

Masimo Wearables is hiring a Regulatory Affairs Specialist II in Irvine, California, responsible for obtaining regulatory clearances for medical devices. The role involves supporting domestic and international submissions, coordinating with regulatory teams, and ensuring compliance with FDA and international standards. Candidates should have a degree in a relevant field and at least two years of experience in the industry. Benefits include medical insurance, a 401(k) plan, and additional perks like flexible spending accounts. #J-18808-Ljbffr Masimo Wearables

Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist II - Medical Devices in Irvine, CA vacancy
  • $75k - $95k

    Masimo Corporation in Irvine, California is seeking a Regulatory Affairs Specialist II to obtain and document regulatory clearances for Masimo...  ...This role requires a minimum of 2 years in a Class II/III medical device environment and knowledge of FDA regulations. The... 
    Medical device

    Masimo Corporation

    Irvine, CA
    5 days ago
  •  ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position:...  ...requirements Ensuring rapid and timely approval of new medical devices and continued approved status of marketed medical... 
    Medical device
    Visa sponsorship
    Relocation package

    Alcon

    Lake Forest, CA
    1 day ago
  • $75k - $95k

    JOB DESCRIPTION Regulatory Affairs Specialist II is responsible for obtaining and documenting domestic and international regulatory clearances...  ...Qualifications A minimum of 2 years of work experience in a medical device Class II/III environment. Working knowledge of FDA or... 
    Medical device
    Work experience placement
    Local area
    Worldwide
    Flexible hours

    Masimo Wearables

    Irvine, CA
    3 days ago
  •  ...Responsibilities Support US and EU regulatory submissions, ensuring protection of...  ...years of hands-on experience in Regulatory Affairs ~ Experience supporting medical devices (Class II and/or Class III) ~ Exposure to global regulatory submissions and compliance... 
    Medical device

    MILLENNIUMSOFT

    Irvine, CA
    3 days ago
  •  ...Regulatory Affairs Specialist This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including... 
    Medical device
    Work at office

    Katalyst HealthCares & Life Sciences

    Irvine, CA
    1 day ago
  • A leading medical device firm located in California is seeking a Regulatory Affairs Specialist to manage global labeling compliance. The role involves owning labeling deliverables for product development, ensuring compliance with various global standards, and managing change... 
    Medical device

    Redbock - an NES Fircroft company

    Irvine, CA
    1 day ago
  • We are looking for an experienced Regulatory Affairs professional with strong expertise in...  ...MDR regulations to support Class II and Class III medical devices across the product lifecycle. Regulatory...  ...Knowledge of FDA submissions and global regulations Excellent analytical,... 
    Medical device

    Soho Square Solutions

    Irvine, CA
    4 days ago
  • Join a pioneering medical technology company dedicated to transforming diabetes management with...  ...world's first bionic pancreas. As an Assembler II, you will play a crucial role in the assembly and packaging of innovative devices that empower users to manage their diabetes... 
    Medical device

    Beta Bionics, Inc.

    Irvine, CA
    1 day ago
  • An innovative medical technology company is seeking an Assembler II to join their team in Irvine, California. This role involves performing electro-mechanical...  ...assembly and packaging of cutting-edge diabetes management devices. Candidates will work in a collaborative environment... 
    Medical device
    Contract work

    Beta Bionics, Inc.

    Irvine, CA
    3 days ago
  •  ...Regulatory Affairs Representative Responsibilities: Represent Regulatory Affairs on cross...  ...planning and regulatory requirements for non-medical devices, and medical devices. Assess the...  ...Experience with US FDA Class I and II medical devices. Additional experience... 
    Medical device

    Katalyst HealthCares & Life Sciences

    Irvine, CA
    1 day ago
  • A leading medical technology company in Irvine is seeking an RD Engineer II to design test methods and support product development. The ideal candidate will have a...  ...regulated industry, and expertise in endovascular device design. You'll deliver top-quality designs and collaborate... 
    Medical device

    Medtronic

    Irvine, CA
    5 days ago
  •  ...Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide...  ...and regulatory requirements for non-medical devices, and medical devices. Assess the...  ...Experience with US FDA Class I and II medical devices. Additional experience... 
    Medical device

    Katalyst Healthcares and Life Sciences

    Irvine, CA
    7 hours ago
  • $125k - $130k

     ...and institutions to develop elegant medical devices. Our products are being used by physicians...  ...devices for stroke. As the premier global neurovascular platform always...  ...About this opportunity - Senior Regulatory Affairs Specialist Description: The Senior Regulatory... 
    Medical device
    Work at office

    BALT Group

    Irvine, CA
    4 days ago
  •  ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity...  ...growing active implantable device portfolio. This role will...  ...partnership with our global R&D, manufacturing, clinical...  ...Affairs experience in the medical industry Prior experience... 
    Medical device
    Work at office
    Local area
    3 days per week

    Intracept by Boston Scientific

    Irvine, CA
    1 day ago
  •  ...knowledge and understanding of global regulatory requirements for new products or...  ...JOB DESCRIPTION The Regulatory Affairs Coordinator III independently supports...  ...activities for U.S. Class II and EU Class II & Class III medical devices across the product lifecycle. This... 
    Medical device
    Work at office
    Remote work

    Rangam

    Irvine, CA
    4 days ago
  • $92k - $130k

     ...Regulatory Affairs Specialist Make a meaningful difference to patients around the world. From...  ...documentation packages for submission to global regulatory agencies Assist with...  ...of global regulations relevant to medical devices, Class II and/or Class III devices Full... 
    Medical device

    Edwards Lifesciences

    Irvine, CA
    4 days ago
  • Regulatory Affairs Specialist (Labeling) Contract through May 2026 - NO C2C, W2 ONLY. A leading medical device team is seeking a Regulatory Affairs Specialist to support global and EU labeling compliance across a wide range of projects. What You’ll Do: Own regulatory... 
    Medical device
    Contract work

    Redbock - an NES Fircroft company

    Irvine, CA
    2 days ago
  • $92k - $148.35k

     ...merit. Job Function: Regulatory Affairs Group Job Sub...  ...Senior Regulatory Affairs Specialist . This role will work a...  ...function such as Quality, Medical, Clinical, R&D. Demonstrated...  ...Prior experience with Class II or Class III Medical Devices strongly preferred.... 
    Medical device
    Contract work
    Temporary work
    Local area
    Immediate start
    Flexible hours
    3 days per week

    J&J Family of Companies

    Irvine, CA
    4 days ago
  • Position Details Position: Asst 1, Global Marketing Mgmt - Onsite (Req Exp in regulated industries (medical devices, pharma, life sciences)) Location: Irvine, CA Duration...  ...Work closely with engineering, clinical, regulatory, and operations teams to support product... 
    Medical device
    Contract work
    Shift work
    Day shift

    MillenniumSoft Inc

    Irvine, CA
    4 days ago
  • $44 - $58.25 per hour

     ...world today and is critical to California global energy transformation. Our mission...  ...LOOKING FOR: MANUFACTURING TECHNICIAN II We are looking for a highly skills...  ...pneumatical systems or equivalent experience in a medical device, aerospace, automotive, or other... 
    Medical device
    Hourly pay
    Full time
    Local area
    Weekend work
    Afternoon shift

    FirstElement Fuel

    Santa Ana, CA
    18 days ago
  • $92k - $148.35k

    Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California (Hybrid...  ...field such as Quality, Medical, Clinical, or R&D. Demonstrated...  ...desired. Prior experience with Class II or Class III Medical Devices strongly preferred. Experience interacting... 
    Medical device
    Contract work
    Temporary work
    Local area
    Flexible hours

    Johnson & Johnson

    Irvine, CA
    5 days ago
  • $80.6k - $133k

    About BD BD is one of the largest global medical technology companies in the world. Advancing the...  ...Engineering group, the Systems Engineer II will play a key role in supporting the...  ...electromechanical instrumentation or diagnostic devices. History working in the medical device... 
    Medical device
    Work at office
    Remote work

    BD

    Irvine, CA
    2 days ago
  •  ...Summary The Senior Engineer II, Algorithm (ECG) is a senior-...  ...algorithms for Masimo’s non-invasive medical device platforms. This role...  ...implementation, verification, regulatory submission, and post-market optimization...  ...Part 820), ISO 13485, and global regulatory requirements.... 
    Medical device
    Work at office
    Monday to Friday

    Masimo Corporation

    Irvine, CA
    2 days ago
  • $87k - $123k

     ...impacts millions of people globally, yet it often remains...  ...patient care with devices supported by clinical evidence...  ...journey.The Engineer II, Supplier Development...  ...alignment with design, regulatory, clinical, and manufacturing...  ...engineering in a medical device industry.Travel... 
    Medical device
    Contract work

    Edwards Lifesciences Gruppe

    Irvine, CA
    2 days ago
  • $87k - $123k

    Join Edwards Lifesciences Gruppe as an Engineer II in Supplier Development, focused on innovating medical devices to improve patient care. In this role, you'll lead initiatives on strategic sourcing, manufacturing readiness, and optimizing design for manufacturability.... 
    Medical device

    Edwards Lifesciences Gruppe

    Irvine, CA
    1 day ago
  • $75k - $100k

     ...Software Quality Engineer II The Software Quality Engineer...  ...of software used in medical devices by ensuring quality, compliance...  ...Engineering, Systems Engineering, Regulatory Affairs, and Product Development...  ...14971, and other applicable global requirements. Participate... 
    Medical device
    Full time
    Work at office
    Flexible hours

    Masimo

    Irvine, CA
    4 days ago
  • $102k - $177.1k

    A global healthcare company is looking for a Global Strategic Marketing Manager to be based in Irvine, California. The role involves...  ...at least three years of marketing experience (preferably in medical devices), and strong analytical skills. This position offers a salary... 
    Medical device

    Johnson & Johnson

    Irvine, CA
    3 days ago
  • $74k - $104k

     ...part of our Clinical Affairs team, you’ll hone...  ..., dedicated medical professionals, patient...  ...advocacy groups, and regulatory authorities, you...  ...of people globally, yet it often remains...  ...patient care with devices supported by clinical...  ...Experience with Class II & III medical... 
    Medical device
    For contractors
    Work experience placement
    Work at office
    Immediate start

    Edwards Lifesciences

    Irvine, CA
    5 days ago
  • MillenniumSoft Inc is seeking a Global Marketing Manager in Irvine, California. The role involves partnering with marketing teams,...  ...Proficiency in PowerPoint and Excel is required, with a preference for medical device experience. This position supports global marketing... 
    Medical device

    MillenniumSoft Inc

    Irvine, CA
    4 days ago
  • A leading global medical devices company is looking for a Global Product Marketing Manager to join their team in Irvine, CA. This role involves collaborating with regional teams to enhance product messaging and market understanding. The ideal candidate holds a Bachelor... 
    Medical device
    Contract work

    MillenniumSoft Inc

    Irvine, CA
    5 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist II - Medical Devices. Be the first to apply!