2 of 2 Remote/Hybrid ISO 13485 Jobs in the UK excluding London

/GCP) Proven track record managing product security in a regulated healthcare or medical device setting Regulatory landscape such as FDA guidance, HIPAA, GDPR, ISO 13485, ISO 14971, AAMI TIR 57, ISO 27001 series, and 21 CFR 820 among others Technical credibility across cloud architecture, network ...

execute verification and validation strategies (including qualified tools and fixtures); and lead design transfer activities. Regulatory Compliance and QMS: Ensure supplier activities operate under ISO 13485 - compliant processes and deliver complete DHF/Technical Documentation regulatory expectations; align development to applicable standards. Risk, Submission and Audit Support: Lead … document risk management (ISO 14971), ensure readiness for UDI, labelling, post market surveillance, and change control, and support regulatory submissions and notified body audits by presenting clear technical rationales and objective evidence. Cross Functional and Stakeholder Integration: Integrate the electronics/software workstream with assay/chemistry, mechanical design ...