Biocompatibility Specialist -REF NHCL06

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

Responsibilities:

·       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.

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