EU MDR Regulatory Affairs Specialist II: AR Liaison

Cook Medical Inc.; Limerick; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Cook Medical Inc. seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorised Representative office.

The role acts as the communication liaison between Cook manufacturers and EU regulatory authorities, supporting post‑market surveillance and regulatory audits. You will maintain strong knowledge of EU MDR requirements across the EU AR scope, collaborate with global teams, vendors, and authorities, and help implement regulatory changes ensuring ongoing compliance for

Qualifikationen

• Third level qualification preferably in Science/Engineering or Law; 2–5 years’ experience in a regulated industry in a similar role desirable.
• Knowledge of ISO, EU, FDA medical device standards/regulations is desirable.
• Good communication and inter‑personal skills.
• Proven problem‑solving skills.

Aufgaben

• Maintain understanding of EU medical device regulations (EMEA incl. UK, Switzerland) and EN ISO13485.
• Liaise with Cook manufacturers and EU regulatory authorities as part of EU MDR compliance.
• Coordinate with EU MDR project teams to implement EU AR duties.
• Maintain QMS processes and procedures for EU AR per EU MDR Articles 11/12.
• Respond to information requests from Competent Authorities and report incidents.

Kenntnisse

Communication skills

Problem solving

MS Office

Organisational skills

Self-motivation

Travel willingness

Ausbildung

Science/Engineering or Law degree

Tools

Regulatory standards knowledge

Jobbeschreibung

Cook Medical Inc. seeks a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorised Representative office.

The role acts as the communication liaison between Cook manufacturers and EU regulatory authorities, supporting post‑market surveillance and regulatory audits. You will maintain strong knowledge of EU MDR requirements across the EU AR scope, collaborate with global teams, vendors, and authorities, and help implement regulatory changes ensuring ongoing compliance for