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

Global Regulatory Affairs Specialist for FDA Submissions

PRISMATIK DENTALCRAFT, INC.

Prismatik Dentalcraft, a division of Glidewell Dental, is seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions. You will lead FDA 510(k)/PMA filings, maintain international registrations, support audits, and develop SOPs while partnering with technical teams to ensure products meet regulatory standards. The role requires interpreting regulations, managing complex documentation, and guiding teams through compliance #J-18808-Ljbffr PRISMATIK DENTALCRAFT, INC.

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Affairs Specialist for FDA Submissions in Irvine, CA vacancy
  •  ...Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate global product registrations and regulatory submissions across markets. The role ensures timely documentation...  .... The successful candidate will manage FDA 510(k) submissions, monitor regulatory... 
    Suggested

    Nihon Kohden Orange Med

    Santa Ana, CA
    3 days ago
  •  ...Jenavalve Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong focus on managing regulatory communication and submissions. The role requires substantial experience in medical device regulations, ensuring compliance with quality standards... 
    Suggested

    JenaValve Technology, Inc.

    Irvine, CA
    2 days ago
  • $92k - $138k

     ...here. Medtronic is a global leader in healthcare...  ...team partners across regulatory, quality, engineering...  ...The Senior Regulatory Affairs Specialist supports regulatory compliance...  ...preparing regulatory submissions, maintaining...  ...Drug Administration (FDA) medical device submissions... 
    Suggested
    Full time
    H1b
    Work at office
    Local area
    Immediate start
    Flexible hours

    Medtronic

    Irvine, CA
    5 days ago
  •  ...cardiovascular and interventional space. As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities across the product lifecycle. This is an... 
    Suggested

    EPM Scientific

    Irvine, CA
    5 days ago
  •  ...Regulatory Affairs Specialist (FDA, DEA)The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare...  .... This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying... 
    Suggested

    BaRupOn LLC

    Irvine, CA
    1 day ago
  •  ...Nihon Kohden Orange Med is seeking a Regulatory Affairs Specialist to coordinate routine regulatory activities across domestic and international markets, supporting product registrations, submissions, and post-market requirements. You will manage regulatory information... 

    Nihon Kohden OrangeMed, LLC

    Santa Ana, CA
    2 days ago
  •  ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual...  ...Regulatory Affairs Specialist is a senior technical expert...  ...the execution of key U.S. FDA submissions—including IDEs, 510(k)s, and...  ...ensuring alignment across global stakeholders and timelines.... 
    Full time
    Contract work
    Remote work
    3 days per week

    KARDION

    Irvine, CA
    2 days ago
  •  ...Senior Regulatory Affairs SpecialistAt Boston Scientific, we...  ...Senior Regulatory Affairs Specialist position (hybrid work...  ...Affairs support of submissions and ongoing...  ...partnership with our global R&D, manufacturing, clinical...  ...Working knowledge of FDA, EU and international... 
    Work at office
    Local area
    3 days per week

    Intracept by Boston Scientific

    Irvine, CA
    2 days ago
  • $76k - $121.9k

     ...Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular....  ...will support preparation, submission, tracking, indexing, and archiving...  ...work closely with other Global Regulatory Affairs partners...  ...product information to US FDA, EU Notified Bodies, and... 
    Temporary work
    Local area

    6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity

    Irvine, CA
    2 days ago
  • $120k - $155k

     ...Lead regulatory strategy and submission activities for Qnovia's drug-device combination products across FDA, MHRA, and other global regulatory bodies. About the Role Qnovia is advancing a...  ...United Kingdom. As a Regulatory Affairs Specialist, you will develop and execute regulatory... 
    Local area
    Flexible hours

    Qnovia, Inc.

    Newport Beach, CA
    4 days ago
  • $95.8k - $159.6k

     ...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical...  ...market while ensuring compliance with global regulatory requirements. In this...  ...you will support regulatory strategy, submissions, and product lifecycle activities across... 
    Temporary work
    Local area
    Flexible hours

    Stryker

    Irvine, CA
    2 days ago
  • $110.1k - $183.4k

     ...Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse...  ...determine regulatory classification, jurisdiction, submission requirements, and approval pathways. Assess regulatory... 
    Temporary work
    Local area
    Flexible hours

    Stryker

    Irvine, CA
    1 day ago
  • Regulatory Affairs Specialist (Labeling) Contract through May 2026 - NO C2C, W2 ONLY. A leading medical...  ...Affairs Specialist to support global and EU labeling compliance across a...  ...product development, sustaining projects, submissions, and manufacturing transfers Ensure... 
    Contract work

    Redbock - an NES Fircroft company

    Irvine, CA
    2 days ago
  •  ...is a division of Glidewell Dental. We are seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions. In this role, you’ll lead FDA 510(k)/PMA filings, maintain international registrations, support audits... 

    PRISMATIK DENTALCRAFT, INC.

    Irvine, CA
    3 days ago
  •  ...Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and...  ...of documentation for medical device submissions and effectively communicate regulatory...  ...years working in a regulated industry (FDA and Software as a Medical Device... 

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    2 days ago
  • $95.8k - $159.6k

     ...Hybrid or OnsiteSenior International Regulatory Affairs SpecialistIrvine, CAJoin a team focused...  ...market while ensuring compliance with global regulatory requirements. In this role,...  ...you will support regulatory strategy, submissions, and product lifecycle activities across... 
    Full time
    For contractors
    Local area

    Stryker

    Irvine, CA
    1 day ago
  • $85k - $130k

    Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful...  ...Notifications and other types of regulatory submissions.Manage international and domestic...  ...and establishment registrations with FDA.Maintain regulatory databases and... 
    Work experience placement
    Local area
    Worldwide
    Flexible hours

    Masimo

    Irvine, CA
    2 days ago
  •  ...is responsible for the preparation of regulatory submissions required to market medical devices in both...  ...registrations and related regulatory affairs activities, including execution of procedures...  ...of industry consensus standards and FDA guidance is required At least 2 years... 
    Work at office

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    5 days ago
  •  ...Functions Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device...  ...Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international... 

    PRISMATIK DENTALCRAFT, INC.

    Irvine, CA
    2 days ago
  •  ...Regulatory Affairs Specialist Responsibilities Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions for products that require government approval. Demonstrates working knowledge of healthcare-related regulations. Demonstrates... 
    Contract work

    Indotronix Avani Group

    Irvine, CA
    4 days ago
  • $80k - $95k

     ...available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating...  ...registrations, regulatory submissions, approvals, and post-market...  ...and Responsibilities Global Product Registrations and Regulatory...  ...submissions, including FDA 510(k) submissions and... 
    Work at office
    Worldwide
    Weekend work
    Afternoon shift

    Nihon Kohden Orange Med

    Santa Ana, CA
    4 days ago
  • $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...  ...proteomic biomarkers. Ensure alignment with FDA expectations for Breakthrough Device Designation... 

    PreludeDx

    Laguna Hills, CA
    1 day ago
  •  ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports...  ...reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs. Perform research to... 
    Immediate start

    ConsultNet Technology Services and Solutions

    Irvine, CA
    3 days ago
  • $83.9k - $120k

     ...Functions Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device...  ...85 Standards. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg... 

    Prismatik

    Irvine, CA
    5 days ago
  •  ...is a leader in innovative global education. We are respected...  ...grow and succeed together! Regulatory Specialist Job Summary The Regulatory...  ...Coordinate the preparation, submission, and maintenance of accreditation...  ...effectiveness, regulatory affairs, or a related field.... 
    Work at office

    Westcliff University

    Irvine, CA
    2 days ago
  •  ...seeking a labeling professional to design, develop and update global labeling documents including product labels, IFUs, implant cards...  ...labels and templates, ensure labeling compliance with QMS and regulatory guidelines, and coordinate with suppliers for outsourced materials... 

    Terumo Neuro

    Aliso Viejo, CA
    3 days ago
  • $90k - $120k

     ...Description Job Description Regulatory Affairs and Quality Assurance Specialist Location: Huntington...  ...compliance with global regulatory requirements...  ...compliance with: EU MDR FDA QSR ISO 13485 / MDSAP...  ...Technical Documentation submissions for the EU, MDSAP... 
    Full time

    SprintRay

    Huntington Beach, CA
    5 days ago
  •  ...similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project...  ...within the IVD industry. Knowledge of FDA, and CE marking requirements for IVD products...  .... Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    2 days ago
  • $85.8k - $137.3k

     ...is a leading technology company for the global information technology ecosystem. With the...  ...reports and SKU lists for Compliance Specialists and ManagementReview and upload approved...  ...SupervisorAdministrative support for required regulatory reporting requirements in a timely... 
    Full time
    Temporary work
    Immediate start
    Worldwide
    Flexible hours

    Ingram Micro

    Irvine, CA
    22 hours ago
  •  ...implementation of US and Canada regulatory strategic and tactical...  ...defined within the Global Regulatory Product...  ...Health Authority (FDA) for key projects/issues...  ...including Public Affairs, Clinical Development,...  ...review of regulatory submissions consistent within US and... 
    Full time
    Local area

    AbbVie Inc.

    Irvine, CA
    a month ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory Affairs Specialist for FDA Submissions. Be the first to apply!