Regulatory Affairs Specialist 2 (CMEU)

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

The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non‑EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities.

Find out more about Cook Medical here

Responsibilities

• Maintain an excellent understanding of the medical device regulations of the EU, (EMEA (Including UK, Switzerland) and EN ISO13485.
• Ensures a thorough understanding of the products they are assigned to from the relevant Cook Manufacturer.
• Work with the global project manager EU MDR and other global and local team members to successful implement the requirements of the EU MDR at the office of the EU Authorised Rep CMEU and/ or sister Cook companies as required.
• Ensures processes and procedures are put in place and maintained as part of the QMS to carry out the role of EU AR as per Article 11 of EU MDR.
• Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts/ Mandates are in place between the EU AR and Cook manufacturers that the EU AR represents.
• Liaise with and respond to request for information and/or documentation/ samples from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions.
• Completes the EU AR obligations as outlined under Art. 11 and 12 of EU MDR
• Completes the EU AR obligations under MDD and per agreements.
• Monitor post‑market surveillance as necessary.
• Identify and monitor legislative and regulatory activities, update processes and procedures as appropriate and report their potential impact on the company to local and global leadership as necessary.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Office of EU Authorised Rep.
• Provides Assistance to Cook UK (UKRP) and the Swiss Representative.
• Provides support to currently marketed products as necessary including input on change requests, PMS etc .
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Provides regulatory support to Cook functional units such as the SSC, tenders, CMEU acting as import/ distributor, customer quality and distribution partners.
• Provides support for regulatory audits.
• Performs additional duties as assigned.
• Acts as RA change analyst .
• Is a delegate for the Regulatory Affairs Specialists, Post Market Surveillance Specialists and Regulatory Scientist .
• Ensure that Cooks Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• T hird level Qualification preferably in Science/Engineering or Law; 2-5 years’ experience in a regulated industry in a similar role desirable
• Knowledge of relevant ISO, EU, FDA medical device standards regulations is desirable.
• Knowledge of medical device quality standards/practises or similar regulated industry.
• Good communication and inter‑personal skills.
• Proven problem‑solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Proven organisational skills.
• High self‑motivation.
• Approved External Auditor.
• Willingness and availability to travel on company business.