Job Type: Director of Regulatory Affairs and Quality Management
Location: Stuttgart
A Stuttgart based leading Medical Device manufacturer, paving the way in discovering treatments for patients within the Spinal industry, the organisation is seeking for a Director of Regulatory Affairs and Quality Management to join their team. You can have a positive impact on the lives of millions of people around the globe. You will have a major impact, shaping the company through your efforts and industry expertise helping them to certify a portfolio of medical devices to multiple markets this year!
Key Responsibilities of the Director of Regulatory Affairs and Quality Management:
- Management and further development of the RA team, so that project goals can be achieved in collaboration with other specialist departments
- Identifying requirements for registrations and approval processes
- Oversight of International approvals for International markets.
- Professional preparation of the organisation for the introduction of the new Medical Device Regulation (MDR)
- To oversee the maintenance of the Quality Management System
- Able to provide training in detail on how documents are processed.
- Preparation, execution and follow-up of audits by authorities and notified bodies
- Lead Regulatory Projects
- Direct report to CEO of the company
Key Requirements of the Director of Regulatory Affairs and Quality Management Include:
- Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
- 5 + years' experience in Medical device industry.
- Knowledge in marketing surveillance report.
- Strong Experience within Technical Files.
- Extensive Background knowledge in MDR Regulations.
Benefits for the Director of Regulatory Affairs and Quality Management:
- Competitive benefits and great personal development opportunities.
- Great atmosphere within a vibrant team.
- Learning & Development Support both internally and externally
- Flexible working hours
- Great reactions between different teams - Chance to explore other departments
- Flat Hierarchy Structure
- Great progression opportunities
