Stellenangebot [](https://www.sebia.com/en-en) ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses/France, ORGENTEC supplies medical laboratories in over 100 countries with highly specialized and innovative devices and test kits. Our company is characterized by steady and sustainable growth in an internationally oriented, future-oriented business field. To strengthen our team at the Mainz site, we are looking for a Project Manager R&D (m/w/d).
Your main tasks:
Project Management of new product development, product improvement and other cross-organizational projects
Support the IVDR program and US launches of selected products for the Mainz site
Establish key milestones, deliverables and monitor project progress
Report on project status, give early warnings and develop plans to mitigate risks
Facilitate team meetings
Lead technical and scientific discussions to drive project completion
Foster the decision-making process
You bring with you:
Scientific education (minimum Master)
Project Management experience or trained in Project Management Methodology
Experience in development of in-vitro diagnostics or medical devices (development of ELISA tests)
Understanding of the Design Control Process and the Development Process
Knowledge of regulations, standards (e.g. IVDR, 510(k), CLSI guidelines), and quality management systems
Comprehensive understanding and ability to analyze scientific study data
Fluent English and German
Timeline and results driven
Lead matrix organizations with multiple stakeholders
Ability to adapt to sudden changes
Find solutions for processes not yet established
Communicate efficiently with different levels in the organization
Ability to manage multiple projects in parallel
Proactive to potential challenges and find resolutions
What we offer:
An open-ended employment contract
A crisis-proof job with an attractive salary
Annual salary review
Flexible working hours
Individual employee development and training
Attractive package of health and social benefits (e.g. allowance for computer glasses, flu vaccination, employer contribution of 30% to private pension scheme)
Employer subsidy for canteen, free drinks
Crèche and kindergarten allowance (max. €200)
Employee discounts with well-known brands
Anniversary bonus
Parking spaces directly at the company
Have we piqued your interest?
We look forward to receiving your application (cover letter, CV, references) by e-mail to [jobs@orgentec.com](mailto:jobs@orgentec.com). Please state your salary expectations and a possible starting date. Orgentec Diagnostika GmbH by Sebia Carl-Zeiss-Straße 49-51 55129 Mainz Germany