Regulatory Affairs Specialist (CEOT)

Job Listing No: 9740000

Regulatory Affairs Specialist (CEOT)

Stryker – Cork – Position Summary Verifies compliance to the European Union Medical Device Regulations (EU MDR) for Stryker products, ensuring fulfilment of regulatory obligations and timely market access in EU countries. Develops and applies basic knowledge and understanding of the RA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Key Activities & Accountabilities Reviews technical documentation including labelling and instructions for use against EU MDR requirements and works with international manufacturing sites to resolve issues Post finalised technical documentation and review checklists to a central repository Facilitates RA flag release for EU MDR compliant products in relevant ERP systems Reports compliance metrics and works with the EMEA RAQA team to plan and deliver documentation reviews to specified timeframes Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the management and international… – Permanent – Full-time

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