Junior Regulatory Affairs Specialist - Medical Devices
Pro-Dex, Inc.
Pro-Dex, Inc. in Irvine, California seeks a Quality Assurance/Regulatory Affairs Specialist to support compliance and quality assurance activities related to medical device manufacturing. The role includes developing regulatory strategies, preparing reports for agency submissions, and maintaining compliance with local, state, and federal regulations. Candidates should have a Bachelor's degree in a related field and experience in quality control or regulatory affairs. Strong technical writing and analytical skills are essential, along with proficiency in Microsoft Office applications. #J-18808-Ljbffr Pro-Dex, Inc.
$60k - $65k
...Supports tasks related to Regulatory and Compliance activities including... ...requirements pertaining to medical device and medical device... ...Quality Assurance or regulatory affairs. One or more years of experience... .../Regulatory Affairs Specialist MENTAL, PHYSICAL AND VISUAL...JuniorMedical deviceApprenticeshipLocal area- ...motivated, friendly, and great on the phone to join our growing team. We work in the medical device industry and are happy to provide on the job product training. This position will start as Junior Sales Representative with the opportunity of becoming part of the Senior Sales...JuniorMedical deviceFull time
- ...Position : Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Clinical Level of Experience : Mid-Level Employment Type : Contract on W2 (Need...Medical deviceContract workDay shift
- ...Regulatory Affairs Representative Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic... ...lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of...Medical device
$90k - $140k
...Regulatory Strategy Lead Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic...Medical device- ...Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance... ...lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess the acceptability of documentation...Medical device
- ...Roles & Responsibilities Support US and EU regulatory submissions, ensuring protection of proprietary information... ...~5-7 years of hands-on experience in Regulatory Affairs ~ Experience supporting medical devices (Class II and/or Class III) ~ Exposure to global...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
- ...Regulatory Affairs Specialist (FDA, DEA) The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare... ...and state regulations related to pharmaceuticals, medical devices, and controlled substances. Key Responsibilities...Medical device
- ...Job Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position... ...Ensuring rapid and timely approval of new medical devices and continued approved status of marketed medical devices...Medical deviceVisa sponsorshipRelocation package
- A leading medical devices company is seeking a Regulatory Affairs Specialist to join their team based in Irvine, CA. The candidate will be responsible for planning and implementing regulatory submissions while ensuring compliance with healthcare regulations. They will...Medical device
$125k - $130k
...collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the... ..., come and join us! About this opportunity - Senior Regulatory Affairs Specialist Description: The Senior Regulatory Affairs...Medical deviceWork at office- ...Senior Regulatory Affairs Specialist At Boston Scientific, we'll give you the opportunity to harness... ...our rapidly growing active implantable device portfolio. This role will be... ...Regulatory Affairs experience in the medical industry Prior experience with 510...Medical deviceWork at officeLocal area3 days per week
- A leading company in pharmaceuticals seeks a Regulatory Affairs Specialist to ensure compliance with FDA and DEA regulations. This role involves... ...sciences or regulatory affairs and relevant experience in the biotech or medical device sectors. #J-18808-Ljbffr BaRupOn LLCMedical device
- A staffing and recruiting company in California is urgently hiring a Regulatory Affairs Specialist. This role involves planning and implementing regulatory submissions for medical devices and requires in-depth knowledge of healthcare regulations. Candidates should have...Medical deviceImmediate start
$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- We are looking for an experienced Regulatory Affairs professional with strong expertise in FDA and EU MDR regulations to support Class II and Class III medical devices across the product lifecycle. Regulatory Affairs Coordinator III What You’ll Do Support U.S. Class II...Medical device
$89.2k - $169.5k
Boston Scientific is seeking a Senior Regulatory Affairs Specialist to join our team in Irvine, CA. The role involves supporting regulatory compliance and submissions for our active implantable device portfolio. Candidates should have a Bachelor's Degree in a scientific...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
- 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...Medical deviceFlexible hours
$92k - $148.35k
...Job Function: Regulatory Affairs Group Job Sub Function... ...Regulatory Affairs Specialist . This role will... ...Guides and trains junior team members on regulatory... ...function such as Quality, Medical, Clinical, R&D.... ...or Class III Medical Devices strongly preferred....Medical deviceContract workTemporary workLocal areaImmediate startFlexible hours3 days per week$92k - $148.35k
Senior Regulatory Affairs Specialist Location: Irvine, California or Milpitas, California... .... Guides and trains junior team members on regulatory... ...equivalent field such as Quality, Medical, Clinical, or R&D.... ...Class II or Class III Medical Devices strongly preferred. Experience...Medical deviceContract workTemporary workLocal areaFlexible hours$75k - $95k
Job Summary Regulatory Affairs Specialist II is responsible for obtaining and documenting domestic and international regulatory clearances to... ...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- 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...Medical device
$92k - $130k
...Regulatory Affairs Specialist Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs... ...knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Full knowledge and...Medical device$25 - $35 per hour
...Job Description We are currently seeking a CNC Machine Operator to support the production of precision components for the medical device industry. Location: Lake Forest, CA (On-site) Schedule: Full time Pay: $25/hr - $35/hr Responsibilities include...Medical deviceFull time$33.8 - $55.8 per hour
...is one of the largest global medical technology companies in the... ...Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented... ...Affairs Associate Specialist to support global product distribution... ...of EU MDR/MDD, FDA medical device regulations, and other...Medical deviceHourly payLocal areaFlexible hoursShift work$40 - $46 per hour
Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated, IT Industries This is an exciting... ...a Global, industry leading company as a Trade Compliance Specialist. Responsibilities Generate SAP reports to present KPIs in...Medical deviceHourly pay- ...Summary: ~ Shift: 2nd Shift Responsibilities: Produce high-quality medical devices within a cleanroom environment. Perform assembly, repair, and test operations on medical catheters under close supervision. Maintain compliance and quality through...Medical deviceShift workAfternoon shift
$80.6k - $133k
...Overview The Advanced Patient Monitoring Regulatory Affairs team is seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global product distribution... .... Knowledge of EU MDR/MDD, FDA medical device regulations, and other international regulatory...Medical deviceFlexible hours
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