EU MDR Regulatory Affairs Lead

Cook Medical Incorporated; Munster; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Cook Medical Incorporated seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorized Representative Office. You will liaise with EU regulatory authorities and Cook manufacturers to implement requirements and maintain QMS processes.

Responsibilities include maintaining EU MDR knowledge, coordinating with global teams, and supporting regulatory audits and post-market surveillance. Travel may be required to liaise with sites and authorities.

Qualifications

• Third level qualification in science, engineering or law.
• 2–5 years of experience in a regulated industry.
• Knowledge of ISO, EU and FDA medical device regulations desirable.
• Strong communication and organisational skills required.
• Willingness to travel for business.

Responsabilités

• Maintain expert understanding of EU medical device regulations (EU MDR, ISO 13485).
• Act as liaison between Cook manufacturers and EU regulatory authorities.
• Collaborate with EU MDR project manager and global/local teams.
• Ensure QMS processes reflect EU AR role per EU MDR Articles 11 and 12.
• Manage regulatory records and respond to information requests from authorities.
• Support regulatory audits and post-market surveillance activities.
• Coordinate multiple regulatory projects and provide regular reports.
• Assist UK and Swiss representatives as needed.
• Ensure code of conduct and compliance in all matters.

Connaissances

Communication

Problem solving

Organisational skills

Self-motivation

Travel availability

MS Office

Formation

Science/Engineering or Law degree

Description du poste

Cook Medical Incorporated seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorized Representative Office. You will liaise with EU regulatory authorities and Cook manufacturers to implement requirements and maintain QMS processes.

Responsibilities include maintaining EU MDR knowledge, coordinating with global teams, and supporting regulatory audits and post-market surveillance. Travel may be required to liaise with sites and authorities.