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Job Details

NEW Biocompatibility Specialist

Company: Thornshaw Recruitment
Location: Limerick
Reference: DB9194R
Closing Date: 09 Jan 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Urgent requirement for Biocompatibility Specialist with global medical device company!

Requirements:

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. 

Responsibilities: 

• 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 
 
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.

For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail your CV to dbolger@thornshaw.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

Apply for this job: NEW Biocompatibility Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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