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ISO 13485 Remote Jobs

46 fresh jobs found

Artificial Intelligence Client Manager
USA - Field Based, United States

Iso 17029 Iso 42001 ISO 27701 ISO 14001 ISO 9001 ISO 13485 Report Writing Software development lifecycle ISO 27001 +8

USD 135K+

Quality Engineer - SaMD
Remote, United States

Medical device QMS Nonconformance evaluations External audits FDA CFR 21 820 21 CFR Part 820 Design Validation Process controls Internal Audits Design verification +51

USD 84K+

Staff Regulatory Affairs Specialist
Remote US

SOP Authoring AI/ML in Healthcare Global Product Registration Submission Preparation Compliance review Regulatory Intelligence Wearable technology 21 CFR 820 EU MDR +20

Senior Full Time

USD 124K+

Product Manager (Medical Imaging Software - ARRT Certification a plus)
Remote, United States

User Interface Expertise Sprint Management Beta Site Management Market Requirements Definition Product requirements definition Pricing Management User Story Development ISO 13485 User Stories +17

USD 118K+

Quality Assurance Auditor
REMOTE- Illinois, United States

Medline Industries, LP

MDSAP MDD Sterilization processes Sterilization Method validation Process Validation MDR ISO Standards Follow-up +22

USD 79K+

Software Design Assurance Quality Engineer
US Remote, United States

Medical device standards Firmware Development Software validation IEC 62304 Design control Medical device industry Neuromodulation ISO 13485 Medical Technology +20

USD 115K+

Cloud Platform Design Assurance Engineer
US Remote, United States

Design control regulations VNS Therapy Cloud data management Software validation Mobile Device Management Medical Device Solutions Vagus Nerve Stimulation Therapy Vagus Nerve Stimulation Medical device industry +24

Senior Mid Full Time

USD 110K+

Expert Coach II
USA - OR - Remote, United States

Clinical best practices Evidence-based principles Data privacy laws Health and wellness Health education ISO 13485 Health benefits Motivational interviewing Virtual care +36

Senior Mid Full Time

USD 60K+

Quality Assurance (QA) Manager, Operations Remote
Durham, NC, US, 27712

Gage R&R 21 CFR Part 820 Materials science ISO 9001 Biochemistry ISO 13485 Biology Calibration Statistical analysis +7

Senior Mid Full Time

USD 160K+

Director, Systems Engineering (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

FTA Usability Engineering PHA Verification Plans HRAs Human Factors Engineering 21 CFR Part 820.30 Traceability Regulatory Approval +33

Exec Senior Full Time

USD 181K+

Complaint Investigator
US-AZ-Remote Location, United States

Agilent Technologies

Workflow troubleshooting IVD Complaint Management 21 CFR 820 Product safety Biological sciences ISO 13485 Materials Instrumentation +24

USD 67K+

Manager/Senior Manager, Regulatory Affairs
Chicago, IL

CAP/CLIA Software validation Clinical decision support Good Clinical Practice Quality Systems ISO 13485 Clinical Care Bioinformatics CAP +25

Senior Full Time

USD 110K+

Account Executive, Surgery Ultrasound (Upstate NY / Northeastern PA )
Remote, United States

Clinical Presentation Ultrasound Imaging Imaging systems Market Assessment ISO 13485 Ultrasound Product Demonstration Diagnostic Imaging Electronics +10

Exec Mid Full Time

USD 70K+

Product Manager (Medical Imaging Software)
Remote, United States

Market Requirements Definition Beta Site Management Sprint Management Product requirements definition Pricing Management User Interface Design ISO 13485 User Stories Diagnostic Imaging +16

USD 118K+

Director, QMS Process Owner – Deviations, Product Quality Complaints, CAPA
Remote (US), United States

ICH Q10 Deviation Management Corrective and Preventive Actions ISO 9001 QMS CAPA Industry Standards Incentive Compensation Change Control +38

Exec Senior Full Time

USD 164K+

Sr. Quality System Specialist (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Quality system regulation Traceability Document Control ISO 14971 QMS Quality Management Systems ISO 13485 FDA regulations ISO +25

Senior Mid Full Time

USD 89K+

Director QMS Process Owner Training and Document Management
Remote (US), United States

ICH Q10 Corrective and Preventive Actions Deviation Management ISO 9001 QMS CAPA Industry Standards GxP Change Control +43

Exec Senior Full Time

USD 164K+

Sr. Director, Global Logistics and Supplier Controls (Remote, US)
Lansing, MI, US

ISO Standards Medical Device Regulations Audit Management FDA regulations ISO 13485 Customer requirements Supplier Management Quality Management Logistics +10

Senior Full Time

USD 200K+

Manager, Quality Assurance
US-Nationwide-FIELD, United States

Cardinal Health Remote-first

Good manufacturing practice ISO 9001 ISO 13485 Pay equity Talent Management Standard Operating Procedures Regulatory standards FDA Quality Control +14

Senior Full Time

USD 103K+

Senior Software Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Helix alm Polarion alm 21 CFR Part 820.30 Requirements writing DOORS FDA guidelines Traceability IEC 62304 Design Controls +41

Senior Full Time

USD 109K+

Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent)
USA - New Jersey - Rahway, United States

Tensile testing ISTA ASTM FDA guidance Machining Manufacturing process development 21 CFR 820 3D CAD Drug product development +88

Senior Mid Full Time

USD 139K+

Sr. Scientist, Device Design Engineer
USA - New Jersey - Rahway, United States

CAE ISTA Tensile testing Dfm Design input requirements ArtiosCAD Tolerance stack ups Dfa ASTM +80

Senior Mid Full Time

USD 114K+

Director Central Quality Audit
Remote, United States

Production Controls CSQE CQA FDA CFR 21 820 CQE Product Quality Improvement Software as a medical device Medical device standards Process controls +53

Exec Senior Full Time

USD 139K+

Customer Quality Manager - Recalls and Device Tracking
US Remote, United States

Device tracking 21 CFR 806 21 CFR 821 Recall management 21 CFR 820 EU MDR Medical Device Regulations Medical device industry ISO 13485 +17

Senior Mid Full Time

USD 125K+

Sr Quality Assurance Auditor
REMOTE- Illinois, United States

Medline Industries, LP

Sterilization processes MDD MDSAP Sterilization Method validation MDR Process Validation ISO Standards Follow-up +24

Senior Mid Full Time

USD 96K+

Senior GCP Auditor
United States of America - Home Based

ISO 14155 Document reviews Clinical Audits QMS CAPA Medical device industry Clinical Practice ISO 13485 CT +18

Senior Full Time

USD 122K+

Principal Scientist, Device Product and Process Development (Director Equivalent)
USA - New Jersey - Rahway, United States

Risk-oriented development Structural finite element analysis Measurement techniques Design failure modes and effects analysis In silico modeling Device characterization FDA guidance Device technology Mechanical Testing +70

Senior Full Time

USD 153K+

Senior Regulatory Affairs Scientist
USA - Remote, United States

Scientific Guidance IVDR Clinical Testing MDR Diagnostic Tools ISO 13485 FDA regulations Biochemistry Statistical methods +20

Senior Full Time

USD 120K+

Software Quality Assurance Engineer
Remote - Texas, United States

Solventum Remote-first

C language Medical device software Gap Assessments Software configuration management IEC 62304 Software Configuration Software Quality Assurance ISO 14971 Task Management +29

Senior Mid Full Time

USD 95K+

Manager, Quality Systems & Compliance - Purchasing Controls - Remote
USA - New Jersey - Rahway, United States

Medical device standards Supplier Audits Purchasing controls Deviations Document management systems Quality Risk Management QMS EU MDR Current good manufacturing practices +66

USD 94K+

Project Manager (Internal Projects)
US-CA-Remote Location, United States

Agilent Technologies

Gantt Chart Management Biological Sciences Knowledge Companion diagnostics ISO 9001 Biological sciences Budget Tracking ISO 13485 Precision Medicine Cross-functional Team Leadership +19

Entry Mid Full Time

USD 105K+

Senior Manager, Clinical Field Operations (Remote)
California, Virtual Address, United States

ISO 14155 Neurovascular technologies Good Documentation Practice Communication technology 21 CFR 820 Clinical protocols Clinical Workflows Good Clinical Practice Techniques +43

Senior Full Time

USD 142K+

Sr Specialist Sterility Assurance
REMOTE- Illinois, United States

Medline Industries, LP

ISO 11137 ISO 11135 Sterilization processes Sterilization Healthcare Products Microbiology ISO 13485 ISO FDA +11

Senior Mid Full Time

USD 96K+

Clinical Consultant, MI - I (Must be certified ARRT or RDMS...Radiology)
Remote, United States

Image Quality Clinical Consulting End-to-end testing Workflow Analysis ISO 13485 Diagnostic Imaging Electronics Field Service Quality Management +14

Senior Mid Full Time

USD 74K+

Associate Director, Quality Assurance - Remote
USA - New Jersey - Rahway, United States

Purchasing controls Preventive action 21cfr820 ICH Q9 21cfr part 4 Combination product development Design Controls Good manufacturing practice Device development +76

Senior Mid Full Time

USD 139K+

Senior Systems Engineer (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Hazards and risk assessments Hazards assessment Helix alm Design trade-off analysis Polarion alm Protocol writing Design Trade-off Verification planning Traceability +54

Senior Mid Full Time

USD 99K+

Clinical Consultant, MI - I (Must be certified: ARRT or RDMS.......Cardiovascular)
Remote, United States

Image Quality Clinical Consulting End-to-end testing Workflow Analysis ISO 13485 Diagnostic Imaging Electronics Technical Assistance Field Service +15

Senior Mid Full Time

USD 74K+

Clinical Consultant, MI - I (Must be certified ARRT or RDMS........Cardiovascular)
Remote, United States

Image Quality Clinical Consulting End-to-end testing Workflow Analysis ISO 13485 Diagnostic Imaging Electronics Technical Assistance Field Service +15

Senior Mid Full Time

USD 74K+

Senior Software Systems Engineer (Remote/Flexible)
US - California (San Diego - Office), United States

Insulet Corporation

Traceability Communication technology Requirements writing Design Controls 21 CFR Part 820.30 QMS FDA guidelines IEC 62304 Software Requirements +35

Senior Full Time

USD 109K+

Senior Software Systems Engineer
US - California (San Diego - Office), United States

Insulet Corporation

Communication technology Helix alm Polarion alm Traceability Requirements writing Design Controls 21 CFR Part 820.30 DOORS QMS +40

Senior Full Time

USD 99K+

Senior Regulatory Affairs Specialist (Remote – United States)
Remote - Texas, United States

Solventum Remote-first

Medical Device Regulations Wound care Corporate policies Strategic growth ISO 13485 Data Tracking Materials Regulatory Affairs Branding +25

Senior Full Time

USD 137K+

Regulatory Affairs Manager (Remote – United States)
Remote - Texas, United States

Solventum Remote-first

Market Authorization Health Authority Interactions Medical Device Regulations Wound care Acquisitions Corporate policies Strategic growth ISO 13485 Strategy Development +28

Senior Full Time

USD 160K+

Sr Regulatory Affairs Specialist (Remote)
USA-CA Northridge, United States

Digital Health Apps Change Notifications Engineering Change Requests Submission Preparation Global Regulatory Strategies Regulatory Documentation Medical Device Regulations ISO 14971 Labeling +36

Senior Full Time

USD 133K+

Expert Coach II
USA - IN - Remote, United States

Evidence-based principles Chronic Condition Management Health and wellness Data privacy laws Health benefits ISO 13485 Health Systems Motivational interviewing Virtual care +36

Senior Mid Full Time

USD 60K+

Senior Regulatory Affairs Specialist (Remote - USA)
Remote - Texas, United States

Solventum Remote-first

Medical Device Regulations Wound care Corporate policies Strategic growth ISO 13485 Data Tracking Materials Regulatory Affairs Branding +23

Senior Full Time

USD 137K+

Complaint Investigator
US-TX-Remote Location, United States

Agilent Technologies

Workflow troubleshooting IVD 21 CFR 820 Product safety Biological sciences ISO 13485 Materials Instrumentation Quality Management System +22

USD 63K+

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