Senior Quality Systems Specialist
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...
of ISO, MDD/MDR, GMP/QSR and other applicable regulations Ability to travel up to 25% Preferred Qualifications...
as regulatory requirements per FDA 21 CFR (US), Medical Device Directive (MDD) & Medical Device Regulations (MDR) (EU... and resource negotiation;and ISO 13485, ISO 5840, and ISO 14971 standards and FDA 21 CFR, MDD or MDR (EU), PMDA (Japan), and TPD...
.​ ​​​Ability to assess current Smith & Nephew practices with external standards (GMP’s, ISO 13485, EN, J-GMP, and MDD), guidance...
of calcified plaque. Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Senior Quality...
to obtain/maintain CE Marking. Review and Maintain (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentation...
trials (e.g., ISO, MDD/MDR, CFR) Experience working on alternative data sources and alternative methods of clinical data...
in audits with FDA, ISO, MDD, and other regulatory agencies. Lead major quality projects that result in CPAR files..., MDD, ISO 9001, and ISO 14971, including experience auditing to these requirements. Experience with all facets of IEC 60601...
-setting activities, and test protocols. Participate in audits with FDA, ISO, MDD, and other regulatory agencies. Lead major... in FDA Quality System Regulation, ISO13485, MDD, ISO 9001, and ISO 14971, including experience auditing to these requirements...
quality system in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International... Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA...