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
$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- ...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 deviceVisa sponsorshipRelocation package
$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 deviceWork experience placementLocal areaWorldwideFlexible hours- ...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
- ...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 deviceWork at office
- 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
- 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
- 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
- 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 deviceContract work
- ...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
- 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
- ...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
$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 deviceWork at office- ...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 deviceWork at officeLocal area3 days per week
- ...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 deviceWork at officeRemote work
$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- 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 deviceContract work
$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 deviceContract workTemporary workLocal areaImmediate startFlexible hours3 days per week- 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 deviceContract workShift workDay shift
$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 deviceHourly payFull timeLocal areaWeekend workAfternoon shift$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 deviceContract workTemporary workLocal areaFlexible hours$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 deviceWork at officeRemote work- ...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 deviceWork at officeMonday to Friday
$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 deviceContract work$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$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 deviceFull timeWork at officeFlexible hours$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$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 deviceFor contractorsWork experience placementWork at officeImmediate start- 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
- 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 deviceContract work
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!
- senior compliance officer Irvine, CA
- compliance associate Irvine, CA
- senior regulatory affairs specialist Irvine, CA
- senior compliance analyst Irvine, CA
- compliance analyst Irvine, CA
- cybersecurity policy and compliance analyst Irvine, CA
- regulatory officer Irvine, CA
- coding compliance specialist Irvine, CA
- compliance consultant Irvine, CA
- risk and compliance analyst Irvine, CA


