EU MDR Regulatory Affairs Specialist II - Liaison

Cook Medical Incorporated; Munster; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

Cook Medical Incorporated is seeking a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorised Representative office. This role acts as a liaison between the Cook manufacturer and EU regulatory authorities, coordinating multiple regulatory activities and maintaining QMS processes.

You will collaborate with global teams, monitor post-market activities, and provide regulatory support across Cook entities, ensuring timely information flow and audit readiness.

Formación

• 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 desirable.
• Good communication and inter-personal skills.
• Proven problem-solving and organisational abilities.
• Willingness to travel on company business.

Responsabilidades

• Maintain an excellent understanding of the medical device regulations of the EU (EMEA including UK, Switzerland) and EN ISO13485.
• Ensure thorough understanding of the products assigned from the relevant Cook Manufacturer.
• Collaborate with the EU MDR project manager and global/local teams to implement EU MDR at the EU AR CMEU or sister Cook entities.
• Maintain processes and procedures as part of the QMS to support EU AR obligations under EU MDR Article 11.
• Maintain contacts with Cook manufacturing sites and ensure contracts/mandates between EU AR and Cook manufacturers.
• Liaise with authorities for information requests and reportable incidents; inform CAs of actions taken.
• Complete EU AR obligations under EU MDR Articles 11 and 12 and under MDD.
• Monitor post-market surveillance as necessary.
• Identify regulatory activities and update processes; report impact to leadership.
• Coordinate multiple projects and provide regular reports to regulatory management.
• Act as a regulatory liaison between Cook Manufacturer and EU AR Office.
• Support Cook UK (UKRP) and the Swiss Representative.
• Provide support for change requests, PMS etc. for marketed products.
• Maintain regulatory records to demonstrate compliance and support regulatory audits.

Conocimientos

Communication

Interpersonal skills

Problem-solving

Organisational skills

Self-motivation

Travel willingness

MS Office

Educación

Science/Engineering/Law degree

Descripción del empleo

Cook Medical Incorporated is seeking a Regulatory Affairs Specialist 2 to ensure EU MDR compliance at the EU Authorised Representative office. This role acts as a liaison between the Cook manufacturer and EU regulatory authorities, coordinating multiple regulatory activities and maintaining QMS processes.

You will collaborate with global teams, monitor post-market activities, and provide regulatory support across Cook entities, ensuring timely information flow and audit readiness.