Product Center Manager (m/w/d)

Job Title

Main Responsibilities

1. Primary contact for medical software products with CE marking
2. Ensuring the basic requirements for the CE conformity declaration
3. Annual review of CE conformity
4. Support in the creation of technical documentation
5. Risk management throughout the product lifecycle
6. Creation of risk assessments in collaboration with the risk management officer
7. Evaluation of potential product risks (e.g., from market observation and quality issues)
8. Submission of the conformity declaration
9. Initiation, support, and approval of design changes (for product safety)
10. Initiation and support of CAPA measures (for product safety and regulatory adaptation)
11. Responsible for post-market surveillance (post-market monitoring)

Your Profile

• Successfully completed bachelor's or master's degree in engineering or a comparable technical field
• Several years of professional experience in research and development, quality management, or in the approval of complex systems
• Comprehensive knowledge of regulatory requirements for medical devices
• High expertise in risk management of medical devices
• Good knowledge of project management
• Very good German and English language skills in speech and writing
• Willingness to occasionally travel on business

Our Offer for You

• The opportunity to work flexibly
• Whether in front or behind the scenes – you help to make better medicine available to more people worldwide
• Individual opportunities for self-determined career planning and professional development
• A company culture in which there is enough room for innovative thinking – to find the best and not the fastest solution together
• A variety of dedicated people with the most diverse competencies, talents, and experiences
• The benefits of a successful global corporation with the collegial culture of a medium-sized company