Job Description
Stellenangebot ()( -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 ( )(mailto: ). Please state your salary expectations and a possible starting date. Orgentec Diagnostika GmbH by Sebia Carl-Zeiss-Straße 49-51 55129 Mainz Germany