Our client is a company with a passion for developing innovative medical devices and making a difference to the well-being of peoples'' lives. Combining manufacturing, training and education, marketing, and customer service under the one roof, they are now well placed to grow their Regulatory Affairs team based at their Headquarters in Switzerland. Stage 1 - a Regulatory Affairs Manager, to lead a project for expanding a database-based system for international registrations
o Ensuring that documentation for international submission will be prepared in joined corporation with the product development, project management and the country organisation
o Interaction with (Regulatory) authorities, and other approving bodies for fast and smooth product approval
o Identify and communicate potential risks in submissions and anticipate regulatory responses through scenario planning
o Maintain international product licenses
o Interaction with country organisations for tracking of objectives
o Support when audited by external bodies
o Regulatory Affairs training of employees to ensure the requirement are understood and followed
o Track legal requirements for the region of responsibility and communicate changes to management as required
This person should typically be degree qualified in the Sciences or Engineering with a number of years working in the Medical Devices industry and actively leading/participating in international medical devices regulations. Knowledge of databases and documentation systems is required. An understanding of Quality System requirements (ISO 13485:2003 and/or ISO 9001) desirable but not a must.
Excellent communication and interpersonal skills are required, as is the need for team work and flexibility in order to deal with the changing environment associated with international medical device regulations. Previous Project lead/management experience is preferred.
Good fluency in written and spoken English is mandatory. Some knowledge of German is useful, while additional languages would be an asset.
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 email@example.com