EU MDR Regulatory Affairs Specialist

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 at the EU Authorised Representative office. You will coordinate with Cook manufacturers and EU authorities to maintain regulatory alignment and support post-market obligations.

The role requires knowledge of EU medical device regulations, strong communication skills, and willingness to travel as needed to support groups across Europe and the UK.

Qualifications

• Bachelor's or higher in science/engineering or law.
• 2–5 years of experience in a regulated industry.
• Knowledge of ISO/EU/FDA medical device standards preferable.
• Strong communication and interpersonal skills.
• Willingness to travel for the role.

Responsibilities

• Maintain understanding of EU medical device regulations (EU MDR, EU AR, UK, Switzerland).
• Coordinate with EU AR and Cook manufacturers to implement EU MDR requirements.
• Maintain QMS processes as per EU MDR Article 11 and 12.
• Liaise with competent authorities and report incidents as needed.
• Provide regulatory support to Cook units and participate in audits.

Skills

Regulated industry experience

Communication

Problem-solving

Organisational skills

Willingness to travel

Education

Science/Engineering or Law degree

Approved External Auditor

Tools

Microsoft Office

Job description

Cook Medical Incorporated seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorised Representative office. You will coordinate with Cook manufacturers and EU authorities to maintain regulatory alignment and support post-market obligations.

The role requires knowledge of EU medical device regulations, strong communication skills, and willingness to travel as needed to support groups across Europe and the UK.