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:
1. Maintain an excellent understanding of the medical device regulations of the EU, (EMEA (Including UK, Switzerland) and EN ISO13485).
2. Ensure a thorough understanding of the products they are assigned to from the relevant Cook Manufacturer.
3. Work with the global project manager EU MDR and other global and local team members to successfully implement the requirements of the EU MDR at the office of the EU Authorised Rep CMEU and/or sister Cook companies as required.
4. Ensure 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.
5. 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.
6. Liaise with and respond to requests for information and/or documentation/samples from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions.
7. Complete the EU AR obligations as outlined under Article 11 and 12 of EU MDR.
8. Complete the EU AR obligations under MDD and per agreements.
9. Monitor post-market surveillance as necessary.
10. 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.
11. Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required.
12. Serve as a liaison on regulatory issues between the Cook Manufacturer and the Office of EU Authorised Rep.
13. Provide assistance to Cook UK (UKRP) and the Swiss Representative.
14. Provide support to currently marketed products as necessary including input on change requests, PMS etc.
15. Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
16. Provide regulatory support to Cook functional units such as the SSC, tenders, CMEU acting as import/distributor, customer quality and distribution partners.
17. Provide support for regulatory audits.
18. Perform additional duties as assigned.
19. Act as RA change analyst.
20. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Qualifications:
1. Third level Qualification preferably in Science/Engineering or Law; 2-5 years’ experience in a regulated industry in a similar role desirable.
2. Ideally have knowledge of requirements of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745, Medical device Directive (93/42/EEC).
3. Knowledge of medical device quality standards/practices or similar regulated industry.
4. Good communication and inter-personal skills.
5. Proven problem-solving skills.
6. Good computer skills including knowledge of Microsoft Office.
7. Proven organizational skills.
8. High self-motivation.
9. Approved External Auditor.
10. Willingness and availability to travel on company business.
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