Regulatory Project Manager, Senior – Medical Devices – Scotland

01.02.2011 by Cgutsell

Job summary:
This is a 6 month contract role to cover maternity leave based in Scotland. My client are looking to pay around £60p/h but will also help towards the cost of travel for those not located within commuting distance. This position is based full time on site.

Main responsibilities
• Provide independent regulatory leadership to cross functional teams for product development.
• Help to develop and define regulatory project plans.
• Responsible for the preparation of global regulatory strategies to support the registration of new and modified products.
• Prepare and submit 510K submissions and CE Mark technical files.
• Liaise with regulatory authorities and notified bodies to address questions and submission issues.
• Manage development and implementation of department projects to improve the effectiveness and efficiency of the department.
• Develop labelling specifications and approve proposed labelling, packaging and promotional material.

For more information please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.

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