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ISO 13485 Remote Jobs

11 fresh jobs found

Senior Manager, Health Hazard Assessment - Remote
Center Valley, PA, US, 18034-0610

Olympus Corporation of the Americas

Health hazard evaluation FDA QSR Field corrective actions 21 CFR 820 ISO 14971 ISO 13485 Cross-functional Team Leadership Regulatory requirements Operational Excellence +7

Senior Full Time

USD 114K+

Associate Principal Scientist, Device Product and Process Development
USA - New Jersey - Rahway, United States

Measurement systems analysis In silico modeling Design failure modes and effects analysis Device characterization ISO 11608 Measurement techniques FDA guidance 21 CFR 820 Analytical Instruments +58

USD 135K+

FCA Program Manager - Remote
USA-MN Mounds View South

Medical device directive FCA strategy ISO 13485 Healthcare Access FDA regulations Audit Support Medical device Reimbursement Regulatory Compliance +10

USD 166K+

Expert Coach II (CDCES)
USA - IL - Remote

Data privacy laws ISO 13485 Health benefits Diabetes education Data interpretation Healthcare experience Motivational interviewing Microsoft Teams Employee Engagement +31

USD 72K+

Vigilance Specialist
US-TX-Remote Location

Agilent Technologies

Vigilance reporting Post market surveillance Product safety Global regulations Training Program Development Adverse event reporting ISO 13485 CAPA SOP Development +19

USD 103K+

Global Head of Quality Assurance, Medical Adhesive Technologies
USA-Virtual

Supplier Quality Management EU MDR Fault tree analysis FMEA CAPA ISO 13485 FDA regulations Quality Management System Regulatory Submissions +6

Exec Senior Full Time

USD 180K+

Senior Regulatory Affairs Specialist (USA - Remote)
USA - Remote

International registrations Clinical evaluations Medical Device Submissions 510k ISO 13485 SOPS Regulatory Affairs Medical device Human Resources +12

Senior Mid Full Time

USD 83K+

Director Central Quality Audit
Remote

Production Controls FDA CFR 21 820 Software Quality Engineering Design Validation Software as a medical device ASQ certification Process controls Medical Device Regulations Lean methodology +39

Exec Senior Full Time

USD 136K+

Associate Director, Device Tech Transfer
USA - Pennsylvania - West Point

Device transfer Manufacturing collaboration Design verification testing Program Leadership Risk communication Design Controls Device development Design verification ISO 14971 +62

Senior Mid Full Time

USD 122K+

Senior Quality Specialist - Remote - Invitae
USA - CA - San Francisco - 1400 16th Street

ISO 820 Quality training NYSDOH ISO 15189 ISO 13485 CAP Lean Six Sigma CLIA FDA regulations +10

Senior Full Time

USD 95K+

Manager, Quality Assurance
USA - NY - Purchase

Gemba walks Installation qualifications Operational qualifications Performance qualifications Gage R&R studies A3 Pareto analysis Fishbone Diagram Fault tree analysis +33

Senior Full Time

USD 150K+

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