Company: Thornshaw Recruitment
Closing Date: 18 Nov 16
Salary (£): Negotiable
Biocompatibility Specialist required for global medical device company!
This is a new role with our client,a global medical device company. The successful candidate will be the subject matter expert in Biocompatibility for Europe. Candidates must have experience with ISO10993.
• Become the Subject Matter Expert (SME) for Company's Biocompatibility processes.
• Maintains an excellent understanding of the global medical device regulations.
• Responsible for implementing regulatory requirements with respect to Biocompatibility as required.
• Maintains a thorough understanding of all products Company 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 Company products is maintained.
• Coordination with external Biocompatibility laboratories on testing required and compilation of requirements to conduct same for example.
• Update of Biocompatibility Assessments on ongoing basis for new testing completed and documenting per SCNs /other changes
• 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.
For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail your CV to email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
|Tel:||00 353 (1) 278 4671|
|Fax:||00 353 (1) 278 4672|
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