Regulatory Affairs Director - Medical Devices

Consult Search & Selection ,
London, Greater London
More Details
Job Type: Full-time

Overview

Regulatory Affairs Director - Medical Devices Salary dependent on experience plus bonus and attractive benefits package Some travel required The Company My client is a successful medical aesthetics business with an impressive product portfolio selling products in over 130 countries. As part of their global growth plan, they have created the exciting new position of Regulatory Affairs Director, to be based out of a new London office and supporting strategy across Europe, Russia and the Middle East. The Opportunity This is a really unique opportunity to branch out this successful organisation's Regulatory Affairs function from the US into the UK. With excellent knowledge of MDD, MDR and ISO13485, as Regulatory Affairs Director it will be your responsibility to lead and participate in the implementation of regulatory strategy in countries across the world - including mainland Europe, Middle East and Russia in particular. Working cross functionally, you will manage regulatory interactions with distributors, consultants and partners. Maintaining communication with Competent Authorities and Notified Body as necessary, some responsibilities include: Driving International approvals Providing regulatory intelligence and keeping abreast of changes in agency regulations and requirements Supporting the conversion from the EU Medical Device Directive to the Medical Device Regulation Managing regulatory interactions with distributors, consultants or partners Ensuring EU in country notifications are completed on time Overseeing the creation and maintenance of agreements between the EU importer and the EU distributors who will be placing the devices on the market Supporting post-market surveillance efforts monitoring the performance of devices Review of International marketing material. About You To be considered for this post, you should demonstrate experience with: Regulatory Affairs Management from a medical device company People management Successful preparation and submission of applications in countries outside of the UK Submission of Technical File and/or Design Dossiers to Notified Body in EU Supporting international registrations. Apply Today Or Contact Sophia at Consult Search & Selection for more information

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