Director, Regulatory Affairs Medical Devices & Combination Product
and management Informs strategy for device-related and combination product aspects of EEA regulatory submissions (e.g., CE-marking...
and management Informs strategy for device-related and combination product aspects of EEA regulatory submissions (e.g., CE-marking...
products, laboratory facilities, and compliance with GMP and GDP standards. Offer advice on CE marking and the requirements...
of product and process changes. Leads or compiles all materials required in CE-Mark and FDA submissions, license renewal...
and execute regulatory pathways (e.g., FDA, EU MDR/CE, global frameworks) for each product category, ensuring compliance... submissions (including 510(k)), EU MDR/CE Mark. Experience with ISO9001:2015, ISO22716, GMP CFR 111, ISO13485. Hands...
with IEC, EN, UL, CE and other relevant standards Liaise with clients, consultants, and internal teams throughout the project... in EPLAN, AutoCAD Electrical, SEE Electrical or similar Experience with CE and UL marking and technical file preparation...
, and risk assessments. Maintain compliance with safety and CE marking requirements through robust documentation and process... systems and mechanisms for long-life, high-performance automation. Good understanding of CE marking, GMP principles, safety...
measurable improvements Your Skills & Experience 2–5 years’ experience working with Microsoft Dynamics 365 CE and/or Power... Platform Strong hands-on experience with Power Apps and Power Automate Experience with Dataverse and Dynamics 365 CE modules...
, transport providers, and internal departments Ensure all certification, CE marking, traceability, and documentation...
clean driving licence essential HGV Licence Category C or CE an advantage Previous experience operating heavy plant...
Job Description: Flexsource are currently recruiting an experienced Artic Driver (CE Licence) for an ongoing domestic... CE Licence Valid CPC & Digital Tachograph Card Previous artic driving experience preferred Good communication...