Hot Regulatory Affairs Jobs

Vigilance Assessor

Reporting to the Director of Human Products Monitoring the role of the Vigilance Assessor is to provide post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the European Union and to provide technical support to the Director of Human Products Monitoring in order to facilitate the effective safety monitoring of medicinal products. A degree in Pharmacy or a PhD with 3 years research experience is essential for this role. Role/Responsibilities: o Signal detection activities using available databases and with integration of quantitative ...

Location: Dublin,

GMP Inspector

GMP Inspector Reporting to a GMP Inspection Manager, the GMP Inspector will be responsible for assessing the compliance of manufacturers with EU Good Manufacturing Practice (GMP). The Manufacturing Compliance Specialist will evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation European Community Directives, Regulations and Guidance. These sites may include; • Manufacturers and distributors of medicinal products. • Manufacturers of investigational medicinal products. • Sites involved in ...

Location: Dublin,

Risk Manager

Risk Manager - Medical Device-User Interface Life Science Recruitment has been exclusively engaged to source a Risk Manager for our client in Dublin. The ideal candidate will demonstrate subject matter expertise in the application of FDA and EU regulations and international standards related to design control, user interface and risk management. The individual must also possess an interest in maintaining an awareness of the device development landscape and have the technical drive and confidence to represent our client from an external perspective where necessary. The Risk Manager will...

Location: Dublin,