LimerickQualification:DegreeExperience:3-4 YearsJob Type:PermanentSalary:Not Disclosed
May be suitable for:
Regulatory Affairs Officer, Regulatory Affairs SpecialistRegulatory Affairs Specialist required for a Limerick based Medical Device facility.We’re currently recruiting for an exciting opportunity with a Medical Device facility based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Essential Duties and Responsibilities may include, but are not limited to, the following: Inputs to development of regulatory strategies and provides guidance and expertise.Compiles and communicates regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.Prepares and presents gap analysis assessments of regulations and guidance’s to peers and cross-functional groups in a concise and precise manner.Reviews and approves the project documentation (design reports, labeling, etc.).Develops tactics supporting first to market commercial opportunities and minimizes time to product launch.
Education and Experience:
A relevant degree and have 3+ years’ experience in a similar position.Experience working on regulatory submissions with exposure to programmable electrical equipment. Knowledge and experience on EU MDR / EU MDD and standards (ISO 13485, ISO 14971 and IEC 60601 series…);Knowledge of FDA and international regulatory requirements is a plus.
For more information contactRuth Hollandon087 7822 [email protected]