Ra Specialist Ii

SIGMAR RECRUITMENT

LIMERICK

RA Specialist II. Work with one of the world’s largest medical device companies on some of their NPI and NPD projects, supporting sustainability and product excellence activities. Responsibilities: Work as part of a large Regulatory Affairs team working on transcatheter heart valves, supporting sustainability activities and being involved in the product lifecycle process development. Prepare and review technical and process information for global submissions while working closely with R&D, DA and Operations. Work on change orders. Support the development of the regulatory strategy for cardiology products. Review and approve documentation. Be a key part of regulatory activities, offering your input and expertise for activities such as labelling. Participate in audits for the likes of FDA, DEKRA and HPRA. Follow and implement the Environmental Management Procedures onsite. Requirements: Level 8 degree in Science or Engineering with 3 years or more experience. Must have solid regulatory affairs or compliance experience. To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1414 days ago