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International Regulatory Specialist

Location:

UK or France

Closing Date:

15 Feb 2012

Salary:

TBC

Description:

This position is responsible for International regulatory affairs and designated regulatory compliance activities including; ensuring timely preparation of submissions for International product registrations, interacts with international affiliates/distributors and representatives of regulatory agencies and Department of Health to assure products and registration submissions comply with country specific requirements. 

 
Ideally you should hold a degree or equivalent in an appropriate technical discipline with experience working with or knowledge of orthopaedic products and/or medical devices, procedures and terminology is strongly preferred. Also preferred is an understanding of quality system requirements, manufacturing knowledge in various areas, packaging, testing, and quality assurance. RAC Certification is a plus. 
 
IT literacy is essential preferably with experience using Word, Excel, Visio, Lotus Notes and experience working with Microsoft Project and AS400 is preferred. Knowledge of SAP would be an asset. Fluency in French is also preferred.
 
This position requires the ability to handle high levels of responsibility, and to work with deadlines. This position also requires strong critical troubleshooting skills, processes ownership, adaptability to fast-paced environment & professionalism.
 
Excellent written and oral communication skills are required, along with the ability to present information clearly & communicate effectively through simple/common terms and language barriers to a variety of different audiences.  Attention to detail and organisation, prioritisation and time management skills are required.
 
Disclaimer: This job description indicated the general nature and level of work expected of the incumbent.  It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent.  Incumbent may be asked to perform other duties as required.
 
To apply, please send your CV and a covering letter to rhiannon.davies@biomet.com by Wednesday 15th February 2012.