New Senior Regulatory Affairs Co-Ordinat

CPL

Limerick

On behalf of my client, a global medical device company, I am recruiting for a Senior Regulatory Affairs Co-ordinator . This is a European focused role in which you will be responsible for ensuring that products already on the market meet with the new medical device regulations. You will be involved in driving projects to implement processes and systems to ensure compliance with regulations. You will report to the Regulatory Affairs Manager and you will have two direct reports. This is a newly created role offering great opportunity for career progression within Regulatory Affairs. Candidates with the following background and experience are invited to apply: Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required. Knowledge of requirements in other jurisdictions where required. 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 desirable. Willingness and availability to travel on company business. For more information and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671. This job originally appeared on RecruitIreland.com.

1834 days ago