Our client, a growing Dublin based pharmaceutical company are currently recruiting for a Regulatory Affairs Officer for medical devices.
Main Objective of Role
Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to EU standards and corporate requirements Manage international regulatory submissions according to company strategy and ensure meeting registration deadlines, via timely answering Health Authorities' queries and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, in order to support the timely introduction of new product into markets Maintain assigned products' Marketing Authorizations via timely variations and renewals submissions and their approvals Build departmental awareness of local regulatory requirements in global markets Compile regulatory component of annual product review and PSUR Archive the registration documentation ace. To internal standards; introduce and regular up-dates to the internal RA database Perform assigned tasks with the highest quality and in accordance to established internal timelines.
Requirements • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree • 1-2 year experience in a regulatory affairs environment • 1- 2 year experience in medical devices. • Detailed knowledge of EU current registration requirements for dossier preparation and procedure running • Deep knowledge of specific national requirements in usual target registration countries • General knowledge of the pharmaceutical industry • Knowledge of Company's internal rules, SOPs and structure • Knowledge of IT tools utilized in RA department
For a full Job Spec and to apply for this role please call Linda on 1 or e-mail
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1