Reporting directly to the Group Regulatory Affairs Manager, you will
* Effectively manage worldwide registration activities including the support / supervision / coordination with external Regulatory Bodies, distributors and subsidiaries, and ensuring the Regulatory Affairs function fully supports the business objectives.
* Drive effective registration strategies to ensure regulatory programmes are standardised to obtain earliest possible approval.
* Creation of new product dossiers where appropriate in line with local country requirements.
* Establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
* Maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.
* Strategically work with New Product Development in the development of new products and technologies delivering first in class regulatory strategy for product commercialization.
* In conjunction with other departments, ensure that the company''s post marketing surveillance responsibilities are fulfilled and support vigilance activities.
* Implement preventative and corrective action programmes as appropriate.
* Deputize regulatory activities in the absence of the Group Regulatory Affairs Manager
* Follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results and adhered to in a fair and consistent manner within the Regulatory Department.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at firstname.lastname@example.org