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Regulatory Affairs Specialist
3 months ago
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.
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 Ensure that Cook’s 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 Ideally have knowledge of requirements of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745, Medical device Directive (93/42/EEC) 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