Biocompatibility Specialist

Cook Medical

Clare, Limerick

The primary function of this position is to manage, develop and maintain the Biocompatibility processes for Cook Ireland. Position: Biocompatibility Specialist. Reporting to: Regulatory Affairs Manager. Responsibilities: Become the Subject Matter Expert (SME) for Cook Ireland’s Biocompatibility processes. Maintains an excellent understanding of the global medical device regulations especially with respect to Biocompatibility for example ISO 10993, and by identifying and critically assessing emerging standards, theories and methodologies and applying gained expertise within the Cook Ireland Biocompatibility processes. Responsible for implementing regulatory requirements with respect to Biocompatibility as required. Maintains a thorough understanding of all products Cook Ireland manufactures. Assessment of Biocompatibility Requirements for new Products, Projects, Changes & Supplier Change notifications (SCNs) and ensuring the evaluation, determination, and documentation of biological safety for all Cook Ireland products is maintained. Coordination with external Biocompatibility laboratories on testing required and compilation of requirements to conduct same for example: samples, quotes, critical review of protocols, reports, etc. Update of Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes. Works closely with the Cook Ireland Regulatory Affairs Specialists to address Biocompatibility aspects for submissions for marketing Authorisations including responding to requests from Regulators. Communication with consultant / toxicologists / peer review within Cook 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. Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required. Maintains and organises appropriate Biocompatibility records to demonstrate compliance with applicable regulations. Performs additional duties as assigned. Qualifications/Requirements: 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. Ability to remain calm and receptive in fast paced situations. 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. Proven problem-solving skills. Good computer skills including knowledge of Microsoft® Office. Excellent organisational and team building skills. High self-motivation. Willingness and availability to travel on company business. This job originally appeared on RecruitIreland.com.

2795 days ago