EU MDR Regulatory Affairs Specialist II: Liaison & Compliance

Cook Medical Incorporated; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Cook Medical Incorporated seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance for EU AR operations. You will liaise between Cook manufacturers and regulatory authorities, maintain QMS processes, and support post-market surveillance.

Travel to partner sites may be required as part of regulatory activities. The role requires a science/engineering or law background with 2–5 years in regulated environments, strong communication, and problem-solving skills to drive regulatory

Qualifications

• Bachelor's degree in Science/Engineering or Law; 2–5 years in a regulated industry desirable
• Knowledge of ISO, EU, FDA medical device standards/regulations desirable
• Knowledge of medical device quality standards/practises or similar regulated industry
• Strong communication and interpersonal skills
• Proven problem-solving abilities
• Strong computer skills including Microsoft Office
• Proven organisational skills
• High self-motivation
• Approved External Auditor
• Willingness and availability to travel for company business

Responsibilities

• Maintain up-to-date understanding of EU medical device regulations (EU MDR, UK, Switz)
• Understand products assigned from Cook Manufacturer
• Collaborate with EU MDR project manager and global/local teams to implement EU MDR requirements
• Maintain QMS processes and procedures for EU AR duties
• Maintain regulatory contacts with Cook manufacturing sites and ensure mandates
• Liaise with authorities for information/document requests; report incidents
• Fulfill EU AR obligations under EU MDR and MDD
• Monitor post-market surveillance as needed
• Identify regulatory changes and update processes
• Coordinate multiple projects and report to regulatory leadership
• Serve as regulatory liaison between Cook Manufacturer and EU AR office
• Support Cook UK (UKRP) and Swiss Representative
• Provide regulatory input for changes, PMS, etc.
• Maintain regulatory records and demonstrate compliance
• Support Cook functions including SSC, tenders, CMEU as needed
• Support regulatory audits
• Perform other duties; act as RA change analyst
• Ensure Cook Code of Conduct in business matters

Skills

Regulatory affairs

EU MDR

Communication

Project management

QMS

GxP

Problem solving

MS Office

Education

Bachelor's degree in Science/Engineering or Law

Tools

Microsoft Office

ISO 13485

Job description

Cook Medical Incorporated seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance for EU AR operations. You will liaise between Cook manufacturers and regulatory authorities, maintain QMS processes, and support post-market surveillance.

Travel to partner sites may be required as part of regulatory activities. The role requires a science/engineering or law background with 2–5 years in regulated environments, strong communication, and problem-solving skills to drive regulatory