Progress prospers with inspiration and curiosity. For 30 years Miltenyi Biotec has been developing products and services that are used in basic research, translational research and cell therapy. Today we are a team of more than 3,000 scientists, physicians, engineers, marketers and numerous other specialists. At Miltenyi Biotec, innovative ideas are being turned into cutting edge products. Together, we are passionate about driving biomedical progress towards curing severe diseases.
You manage a product line of regulated reagents (IVD/ASR/GMP), while establishing strong connection to customers and the opinion leaders in the market. You translate user/customer requirements into design input, during development processes and product realization phases.
You are responsible for the definition of new products under Quality Management system, providing feedback from customers and working closely with R&D and other departments to ensure the products meet user needs.
You will work closely with System Engineering, Quality Assurance and Regulatory Affairs to enable successful regulatory filings in Europe (for e.g. IVDR/IVDD).
You are responsible for coordinated product management and coordination of participating business units including R&D, Quality Assurance, Production, Sales, Marketing Communications.
You develop training on product positioning/messaging throughout the year as-needed (e.g. for new products, to deal with competitor changes, pricing and promotion changes, product performance changes).
Through regular market monitoring, analysis of market data/trends and direct interaction with key opinion leaders, you develop IVD application areas and provide requirements for future technology development.
You have an advanced degree in business administration, medicine, engineering or natural sciences and at least 1 year of professional experience on product management, product development, quality assurance, regulatory affairs or other relevant business units in the area of medical devices or in vitro diagnostic tests.
You have a proven practice-oriented knowledge of IVD-directive and DIN EN ISO 13485 and standard and Code of Federal Regulations (CFR) 21§ 820.30.
Experience in documentation to support ISO, CE mark, 510(k) and/or PMA submissions, complete your profile.
Moreover, you have communication and time management working skills and like to interact in multi-disciplinary teams.
Personally you are characterized by a solution-oriented way of working as well as a high level of drive.
What we offer
A modern workplace and exciting opportunities in the development of technologies with a secure future
Cross-border intercultural cooperation and short communication channels
A collegial corporate culture and flexible working hours enable time management on your own terms
Personalized employee development program: specialist and personal training courses provided by our own training academy
Diverse corporate benefits with regard to employee health, sport, and staff events
If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for.