Commutable from Dortmund, Essen, Duisburg, Münster, Hamm and surrounding areas
A global manufacturer of innovative digital technology devices with 15+ years of expertise. 100+ dynamic employees are occupied in offices near Essen and in the US, offering an international feel and global remit.
They specialize in different industries and this position will focus on the medical device market covering Class I and Class IIa electrical medical devices.
The company continues to expand in Europe, APAC and the US and are a market leader in their field. The team is extremely engaged in partnerships, R&D and digital advancements in the medical industry and are looking to strengthen their RA/QM department with a new employee, eager to take on the challenge!
• Reporting to the Managing Director and working with colleagues in regulatory affairs and quality management
• Position focused on the preparation of technical documentation for international and national product registrations under MDD/MDR and FDA
• Coordination of product releases in different markets and support the development team
• Registration of Class I and IIa medical devices in Europe US and Canada, and supporting registrations worldwide
• Manage contact and interactions with Notified Body and local authorities
• Internal and external audits to ISO 13485 with suppliers and Notified Bodies
• Continuous development of the QMS to ISO 13485
• Manage the CAPA process
• This position is broad and will suit you if you search for autonomy and full visibility over QM/RA activities.
• 2+ years of experience in RA/QM activities for medical devices
• Experience in EU regulatory submissions and approvals with knowledge/practical experience with the MDR
• Working with the QMS to ISO 13485 and involved in auditing process
• Engineering/Scientific Degree, or similar
Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+44 208 638 5376