|Job Title:||Biocompatibility Specialist|
|Contact Name:||Laurentina Kennedy|
|Job Published:||over 3 years ago|
Our client is a global medical device organisation requires a Biocompatibility Specialist
The Biocompatibility Specialist will be a Subject Matter Expert for Biocompatibility processes. This is a permanent role based in Limerick.
This role is reporting into the Regulatory Affairs Manager
Become the Subject Matter Expert (SME) for 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 Biocompatibility processes.
Responsible for implementing regulatory requirements with respect to Biocompatibility as required.
Maintains a thorough understanding of all products 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 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 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 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.
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.
Willingness and availability to travel on company business.
For further information on this position Biocompatibility Specialist please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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