We are actively seeking to recruit a Biocompatibility Specialist to become a key member of the Quality team within a leading Munster based medical device multinational
The primary function of this position is to manage, develop and maintain the Biocompatibility processes
· Become the Subject Matter Expert (SME) for the Biocompatibility processes
Maintain an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993.
· Responsible for implementing regulatory requirements with respect to Biocompatibility as required.
· Assessment of Biocompatibility Requirements for new Products, Projects, Changes & Supplier Change notifications (SCNs)
· Coordination with external Biocompatibility laboratories on testing required and compilation of requirements to conduct same.
· Update of Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes
· Works closely with the Regulatory Affairs Specialists to address Biocompatibility aspects for submissions for marketing Authorisations.
· Communication with consultant / toxicologists / peer review as necessary
· A primary contact for Biocompatibility working groups / training going forward
· Work closely to build effective relationships with other functions in particular Operations, Quality and Engineering.
Qualifications and Experience:
· Third level Qualification preferably in Science, 5 years’ experience in a regulated industry in a similar role is desirable.
· Understanding of applicable guidelines and regulations, for example experience with ISO 10993
· Demonstrated ability to manage and execute multiple projects
· Ability to work in collaborative and independent work situations and environments with minimal supervision
· Strong interpersonal skills and the ability to communicate at all levels of the organisation.
· Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.
· Good computer skills including knowledge of Microsoft® Office.
· Excellent organisational and team building skills.
· High self-motivation.