Senior Regulatory Affairs Specialist

CPL

Limerick

The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the. regulatory affairs by providing input into: regulatory strategies, performing activities. associated with obtaining and maintaining regulatory approval to commercialise. medical devices in selected target markets and providing regulatory affairs. input for the functional areas. The successful candidate will report to the Regulatory Affairs Manager. Applications are invited from candidates with the following background and experiece: • Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated. industry in a similar role is desirable. • 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 otherjurisdictions where required. • Knowledge of medical device qualitystandards/practises or similar regulated industry. • Good communication and inter-personalskills. • Proven problem-solving skills. • Good computer skills including knowledge ofMicrosoft® Office. • Proven organisational skills. • High self-motivation. • Willingness and availability to travel on company business. For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail your CV to 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.

2731 days ago