Zyagnum AG is a biotechnology company with the aim of making serious diseases visible, and therefore treatable, at the earliest possible stage. We are convinced that many diseases can be better treated and cured the earlier they are discovered. We therefore believe that the key to curing the major unsolved medical problems of our time lies in early detection diagnostics.
Since 2007, we have been working on the development of technologies with which these widespread diseases can be detected earlier. The result of this intensive development period is our proprietary EDIM® technology.
With around 50 employees at the Darmstadt site and numerous close business partners in Germany and abroad, we are now working on the implementation of our ideas for diagnostics.
The core of our prevention work is our diagnostics laboratory. Our diagnostic focus is on a specially developed technology in the field of immuno-oncological flow cytometry.
Your tasks at a glance
- As a Senior Quality and Regulatory Manager, you will play a critical role in ensuring that our products meet industry regulations and quality standards. Together with the QMB and PRRC, you will be responsible for managing the quality management system, ensuring compliance with regulatory requirements and promoting a culture of continuous improvement.
- Maintaining and developing the company’s Quality Management System (QMS) in accordance with ISO 13485 and 2017/746 IVDR standards.
- Ensure that all applicable regulatory requirements are met and be the primary point of contact for audits and inspections.
- Lead audits (internal audits and external audits including supplier audits) and implement effective CAPA processes, document control and management review.
- Collaborate with cross-functional teams to ensure quality and regulatory requirements in product development processes and to integrate, maintain and further optimize post-market surveillance.
- Responsible for regulatory requirements for product development and ensuring and evaluating implementation.
- Collection of data on product performance (incl. customer surveys, market analyses) and preparation of annual reports on performance and safety, market observation and post-market observation (performance evaluation reports, PMS reports / periodic safety update reports, post-market performance follow-up reports).
- Registration of products in databases and maintenance of data entries.
The skills you need
- Bachelor’s or Master’s degree in the field of natural science.
- At least 5 years’ experience in a similar role with a focus on in-vitro diagnostics.
- In-depth knowledge of ISO 13485 and 2017/746 IVDR.
- Proven track record of working successfully with regulatory authorities and notified bodies.
- Strong project management skills with the ability to prioritize and manage multiple tasks simultaneously.
- Excellent communication and interpersonal skills.
- Very good command of written and spoken German and English.
- Problem solving: Demonstrate a proactive and analytical approach to problem solving.
- Adaptability: Thrive in a fast-paced, evolving environment and adapt strategies to changing requirements.
- Communication: Communicate complex regulatory and quality information clearly to different audiences.
- Collaboration: Foster a collaborative and inclusive work environment and encourage cross-functional collaboration.
We offer
- A versatile and varied workplace in a motivated team
- Varied tasks with a lot of personal responsibility
- Permanent employment in a fast-growing, innovative company
- Company bike
- Cancer scan insurance
- Pension insurance
Please send your detailed application with your earliest possible entry date and salary expectations by e-mail to: personal@zyagnum.com
Or by post to:
Zyagnum AG
z. Attn. Ms. Meike Herzbruch
Gräfenhäuser Str. 26
64293 Darmstadt
Your tasks at a glance
- Support in project management and participation in day-to-day operations
- Administration of customer software tools
- Collaboration and handling of communication with partners, customers and employees
- Telephone customer support
- Creation of process documentation and status reports as well as administrative activities
The skills you need
- Structured, well-documented work
- Ability to work in a team, flexibility, great willingness to learn
- Enthusiasm for new challenges and goal-oriented implementation of solutions
- Degree in a relevant subject (e.g. business administration, business administration, international management) or comparable commercial training
- Very good written and spoken German and English skills
- proficiency with MS Office (Excel)
We offer
- A diverse and varied workplace in a motivated team
- Independent and team-oriented work
- Research laboratory with state-of-the-art equipment
- Permanent position in a rapidly growing, innovative company
Please send your detailed application with your earliest possible entry date and salary expectations by e-mail to: personal@zyagnum.com
Or by post to:
Zyagnum AG
z. Attn. Ms. Meike Herzbruch
Gräfenhäuser Str. 26
64293 Darmstadt
Your tasks at a glance
- Detailed knowledge of the application of PanTum Detect
- Laboratory handling and processing of blood samples (intracellular immunofluorescence staining for flow cytometric measurement)
- Support of external partners with regard to test application and devices
- Operation of flow cytometric devices for the measurement of blood samples
- Assessment of the measurement results to check the staining quality
- Flexible travel to support the partner laboratories
The skills you need
- Successfully completed vocational training as a chemical technician, BTA, CTA, PTA or studies in biotechnology or process engineering or similar
- Routine handling of single-channel and 8-channel pipettes
- Basic experience in flow cytometry (e.g. BD-Canto, BD Lyric)
- Basic knowledge of programming for application scripts (e.g. Freedom EVO100 aspiration robot)
- Very good knowledge of Microsoft Office applications (especially Word, Excel and PowerPoint) and an affinity for digital processes
- Very good written and spoken English skills
- Willingness to work with external partners
- Willingness to travel worldwide to establish the PanTum Detect in partner laboratories
We offer
- A diverse and varied workplace in a motivated team
- Independent and team-oriented work
- Research laboratory with state-of-the-art equipment
- Permanent position in a rapidly growing, innovative company
Please send your detailed application with your earliest possible entry date and salary expectations by e-mail to: personal@zyagnum.com
Or by post to:
Zyagnum AG
z. Attn. Ms. Meike Herzbruch
Gräfenhäuser Str. 26
64293 Darmstadt
Job type: Full-time, permanent position
Benefits:
- Company pension scheme
- 30 days vacation
- Free drinks
- Corporate benefits
- Job bike leasing
- KrebsScan insurance
Place of work: On site with travel
Expected starting date: 01.11.2023
Bitte richten Sie Ihre aussagekräftige Bewerbung mit frühestmöglichem Eintrittstermin sowie Ihrer Gehaltsvorstellung per E-Mail an:
personal@zyagnum.com
Oder auf dem Postweg an:
Zyagnum AG
z. Hdn. Frau Meike Herzbruch
Gräfenhäuser Str. 26
64293 Darmstadt