Regulatory Affairs Specialist 2 (CMEU)

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 for EU AR operations. You will liaise between Cook manufacturers and regulatory authorities, maintain QMS processes, and support post-market surveillance.

Travel to partner sites may be required as part of regulatory activities. The role requires a science/engineering or law background with 2–5 years in regulated environments, strong communication, and problem-solving skills to drive regulatory

Qualifications

• Bachelor's degree in Science/Engineering or Law; 2–5 years in a regulated industry desirable
• Knowledge of ISO, EU, FDA medical device standards/regulations desirable
• Knowledge of medical device quality standards/practises or similar regulated industry
• Strong communication and interpersonal skills
• Proven problem-solving abilities
• Strong computer skills including Microsoft Office
• Proven organisational skills
• High self-motivation
• Approved External Auditor
• Willingness and availability to travel for company business

Responsibilities

• Maintain up-to-date understanding of EU medical device regulations (EU MDR, UK, Switz)
• Understand products assigned from Cook Manufacturer
• Collaborate with EU MDR project manager and global/local teams to implement EU MDR requirements
• Maintain QMS processes and procedures for EU AR duties
• Maintain regulatory contacts with Cook manufacturing sites and ensure mandates
• Liaise with authorities for information/document requests; report incidents
• Fulfill EU AR obligations under EU MDR and MDD
• Monitor post-market surveillance as needed
• Identify regulatory changes and update processes
• Coordinate multiple projects and report to regulatory leadership
• Serve as regulatory liaison between Cook Manufacturer and EU AR office
• Support Cook UK (UKRP) and Swiss Representative
• Provide regulatory input for changes, PMS, etc.
• Maintain regulatory records and demonstrate compliance
• Support Cook functions including SSC, tenders, CMEU as needed
• Support regulatory audits
• Perform other duties; act as RA change analyst
• Ensure Cook Code of Conduct in business matters

Skills

Regulatory affairs

EU MDR

Communication

Project management

QMS

GxP

Problem solving

MS Office

Education

Bachelor's degree in Science/Engineering or Law

Tools

Microsoft Office

ISO 13485

Job description

Overview

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 Article 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

• Third 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.