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Regulatory Specialist - Medical Devices Jobs

1,026 Jobs

  • 5.0
    Aptonet Inc – Ball Ground, GA
    EASY APPLY
    NEW
    Regulatory Affairs Specialist What Your Day-to-Day Activities Will Be Ensure product/process compliance with the requirements… MedicalDevice Industry Experience Experience with Quality Management System (QMS) Design Controls medical devices…
  • 3.3
    Becton Dickinson and Company – Sparks, MD
    $70k-$98k(Glassdoor est.)
    NEW
    international medicaldevice and in vitro diagnostic device (IVD) regulatory requirements. Minimum 3 years experience in the device/diagnostic… interprets U.S. and international medicaldevice and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance…
  • 2.9
    Apex Life Sciences – Monrovia, CA
    $42k-$62k(Glassdoor est.)
    Today 3hr
    Maintain technical knowledge of devices in area of responsibility. Maintain up-to-date on global regulatory requirements. Represent… provide regulatory support when needed. Review complex reports, validations, etc. for scientific merit and regulatory appropriateness…
  • 3.4
    Dentsply Sirona – York, PA
    $52k-$74k(Glassdoor est.)
    6 days ago 6d
    experience in regulatory affairs for a pharmaceutical, biotech, or medicaldevice company. Experience with Class III medicaldevice manufacturing… worldwide. The Regulatory Affairs Specialist is responsible for the development, retrieval and maintenance of regulatory submissions…
  • 2.8
    Chart Industries – Canton, GA
    $57k-$81k(Glassdoor est.)
    14 days ago 14d
    Ground Facility is currently looking for a Contract RegulatorySpecialist to join our operations in Ball Ground. The contract… with U.S. FDA 510K submittals as well as international medicaldevice approvals. Good communication skills at all levels (written…
  • 3.1
    ArisGlobal – Chicago, IL
    $49k-$83k(Glassdoor est.)
    NEW
    biotechnology and medicaldevice) companies in the management of their clinical trials, drug safety and regulatory information. Our… application suite within the regulatory domain. Expected to be and remain specialists within the Regulatory field and will build key…
  • 5.0
    KSE Partners – Charlton, MA
    NEW
    assessment for new devices. Determine regulatory requirements for changes/modifications made to the 510(k) or PMA device(s), and/or… ’ Federal Code of Regulations for medicaldevices and Health Canada: Canadian MedicalDevices Regulations. Job Function…
  • 4.4
    Aequor Technologies – Fort Worth, TX
    Today 9hr
    experience in a medicaldevice setting – ophthalmology and O.R preferred  1-3 years relevant work experience (i.e. device/drug safety… safety, compliance, quality assurance, regulatory affairs)  Excellent time management and prioritization skills  Ability to…
  • 3.8
    Planet Pharma – Fort Worth, TX
    Today 6hr
    experience in a medicaldevice setting - ophthalmology and O.R preferred 1-3 years relevant work experience (i.e. device/drug safety… safety, compliance, quality assurance, regulatory affairs) Excellent time management and prioritization skills Ability to work effectively…
  • 3.9
    Rush University Medical Center – Chicago, IL
    7 days ago 7d
    therapies and medicaldevices, as well as to expand scientific and medical knowledge. Rush University Medical Center is a three… clinical research experience required. Experience drafting regulatory, compliance, or legal documents required. Ability to exercise…
  • 4.1
    Millenniumsoft INC – San Jose, CA
    $63k-$98k(Glassdoor est.)
    NEW
    experience working in a medicaldevice environment. A minimum of 2 years prior experience working on product regulatory submissions.… Regulatory Affairs Specialist San Jose, CA 12 Months contract 8 AM to 5 PM Weekly 40.00 hours [ Mon - Fri] Qualifications…
  • 5.0
    CorTalent – Minneapolis, MN
    NEW
    regulations. Supervise the Regulatory Group including: IND/IDE and ClinicalTrials.gov Specialist, and Clinical Trial Monitors… Support/Regulatory staff, including: regulatory consulting, IND/IDEs, and ClinicalTrials.gov. Monitor CTSI Regulatory Service…
  • 3.7
    Masimo Corporation – Irvine, CA
    $61k-$91k(Glassdoor est.)
    Today 40min
    or electronic device products; Knowledge of regulatory submission requirements for FDA Class II medicaldevices, and equivalent… domestic regulatory requirements, the incumbent will be a key person in making it happen. The incumbent's medicaldevice regulatory…
  • 3.3
    Verathon – Bothell, WA
    $81k-$122k(Glassdoor est.)
    9 days ago 9d
    required Demonstrate regulatory affairs knowledge in product submissions and regulatory topics for medicaldevices including: 510(k… demonstrate knowledge of regulatory procedures, enforce company policies for design control and medicaldevice regulations; and, participate…
  • 3.7
    CodeForce 360 – San Jose, CA
    $72k-$108k(Glassdoor est.)
    Today 6hr
    working in a medicaldevice environment. · A minimum of 2 years prior experience working on product regulatory submissions.… Job Description Position: Regulatory Affairs Specialist Location: San Jose, CA 95131 Duration: 12 Months Minimum Qualifications…
  • 3.7
    Karl Storz Endoskope – Charlton, MA
    Today 8hr
    assessment for new devices. Determine regulatory requirements for changes/modifications made to the 510(k) or PMA device(s), and/or… ’ Federal Code of Regulations for medicaldevices and Health Canada: Canadian MedicalDevices Regulations. Job Function…
  • 4.0
    Roche – Pleasanton, CA
    NEW
    minimum of 7 years of related experience specifically in the medicaldevice industry and authoring submissions in multiple countries… Pleasanton Function Regulatory Affairs Subfunction Diagnostics Rest of World Regulatory Affairs Schedule Full-time…
  • 3.0
    Invivoscribe – San Diego, CA
    EASY APPLY
    $51k-$73k(Glassdoor est.)
    23 days ago 23d
    adverse event reports. Submits required medicaldevice reports. Provides regulatory guidance to other departments. Cooperates… Regulatory Affairs Specialist II San Diego, CA #JGRASII REPORTS TO Director of Regulatory Affairs & Quality…
  • 3.4
    Nordson Corporation – Eagan, MN
    $49k-$70k(Glassdoor est.)
    22 days ago 22d
    experience in Regulatory Affairs in a medicaldevice company Must have experience working with Class II medicaldevices Good working… Responsibilities include implementing regulatory plans and complete regulatory deliverables for medicaldevices. ESSENTIAL JOB DUTIES &…
  • 3.9
    APN Software Services Inc. – Norwood, MA
    NEW
    global manufacturer of medicaldevices. Experience with managing and preparing International Regulatory Submissions (CE Mark Technical… material and device labeling for regulatory compliance. Preferred Skills: Minimum five years experience in Regulatory Affairs…
  • 3.4
    Baxter – Dixon, CA
    $39k-$57k(Glassdoor est.)
    Today 6hr
    is an essential function of every Baxter employee. Service Specialists are required to: Understand and follow (DOT) requirements… Work in a safe manner, obeying rules of the road and other regulatory requirements Follow safety rules including equipment use…
  • 3.5
    Cardinal Health – Mansfield, MA
    $47k-$71k(Glassdoor est.)
    NEW
    Description The Senior RA Specialist will provide regulatory support on a range of medicaldevices and activities which include… change notifications, device listings, UDI submissions, etc. In collaboration with International Regulatory Affairs, determine…
  • 3.5
    Medtronic – Fridley, MN
    $61k-$81k(Glassdoor est.)
    1 days ago 14hr
    years industry experience Quality Assurance or Regulatory Affairs for a MedicalDevice or Pharmaceutical Industry. DESIRED/PREFERRED… and international regulatory agency requirements, CE marking (AIMD and MDD). Experience with medicaldevices (510(k), PMA), pharmaceuticals…
  • 3.5
    Medtronic – Santa Rosa, CA
    $89k-$115k(Glassdoor est.)
    1 days ago 14hr
    Senior Regulatory Affairs Specialist will provide regulatory affairs support for Class II and Class III medicaldevices including… Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and…
  • 3.7
    NxStage – Lawrence, MA
    $49k-$69k(Glassdoor est.)
    HOT
    directly with patients and/or dialysis equipment 3+ years of medicaldevice technical customer support experience Exceptional troubleshooting… troubleshooting ability and technical expertise in electromechanical medicaldevice products Computer/ERP experience and an understanding…
  • 3.5
    Spectraforce Technologies Inc – San Jose, CA
    1 days ago 21hr
    working in a medicaldevice environment. A minimum of 2 years prior experience working on product regulatory submissions.… Previous experience working for a medicaldevice manufacturer. Knowledge of regulations related to product lasers. Experience…
  • 3.8
    AtriCure – Minneapolis, MN
    $86k-$121k(Glassdoor est.)
    HOT
    required A minimum of 10 years of regulatory affairs working experience, for medicaldevices. Must have knowledge of U.S. and European… Position Summary: The Principal International Regulatory Affairs Specialist originates appropriate documents to obtain and maintain…
  • 5.0
    Aptonet,Inc. – Canton, GA
    19 days ago 19d
    Job Description Specialist, Regulatory Affairs Specialist - Job ID 9808152 Experience Required Experience and working knowledge… MedicalDevice Industry Experience Experience with Quality Management System (QMS) Design Controls – medicaldevices
  • 3.3
    BD – San Jose, CA
    $100k-$135k(Glassdoor est.)
    1 days ago 15hr
    Description The Sr. Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required… experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Ideal…
  • 4.6
    ProClinical Limited – United States
    $42k-$66k(Glassdoor est.)
    7 days ago 7d
    pharmaceutical or medicaldevice company, with an understanding of EU or US Regulatory requirements for pharmaceutical/medicaldevice products… to find a Regulatory Affairs Specialist. The role will focus on writing, compiling and submitting a range of Regulatory documents…
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