Project Manager - Regulatory Affairs

IrishJobs

Limerick, Wexford, Ireland

Limerick, Wexford, Ireland

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À propos

Project Manager Regulatory Affairs Hybrid Role We are actively looking to recruit a Project Manager with a background in Regulatory Affairs for a Limerick based Medical Device Multinational. Job responsibilities would include: Establish project plans with associated milestones and deadlines. Communicate with stakeholders throughout projects. Act as a single point of contact and provide coordination of deliverables. Develop strong relationships with all stakeholders to create high-functioning global project teams. Ensure that projects are completed on schedule and with appropriate documented approvals to meet operational targets Oversee routing, tracking, and archiving of project documentation. Identify, document, and facilitate resolution of project risks and issues. Provide coaching and guidance to relevant team members in best project practices. Develop and review project status reports with relevant team members. Follow up on needed changes as required. Process Development and Improvements Develop and document resource information and summaries. Facilitate project status meetings and other meetings as required. Ensure training completed for users on new systems and processes. Qualifications and Experience 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, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required. Knowledge of requirements in other jurisdictions where required. Knowledge of medical device quality standards/practices or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. For more information and a full job spec please forward your CV in the strictest confidence to the link provided Skills: Project Manager Regulatory Affairs Medical Device ISO13485

TLNT1_IJ

Limerick, Wexford, Ireland

Compétences linguistiques

English

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