Scientist, Engineer as Regulatory Affairs Manager - Medical devices (m/w/d)

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.

Miltenyi Biotec continues to grow. Our corporate culture encourages you to shape your own ideas and to create a new dynamic. Welcome to a team that thrives on innovation.

Regulatory Affairs Manager (m|w|d)

Your Role

  • As Regulatory Affairs Manager you actively support the registration of medical devices in the APAC region with focus on South Korea which is the basis for market access and use of the products in Cell and Gene Therapy.
  • Your main task is the compilation and maintenance of marketing authorization files based on the regulatory classification of products and the identification of regulatory pathways.
  • A further focus is the supervision of regulatory compliance in close cooperation with the RA team and the colleagues of the Quality Assurance, Quality Control, Development and Production departments.
  • Identification, understanding and communication of the specific regulatory requirements and applicable standards in each APAC region is crucial for the interaction with subsidiaries, distributors, consultants and regulatory authorities.

Your Profile

  • You have completed your scientific or engineering studies, preferably in the field of biotechnology or medical technology, with a Master's degree.
  • Experience with medical devices would be highly beneficial. Ideally, you have already gained experience with regulatory affairs. We are also happy to give young professionals a chance – your motivation is what counts.
  • With your communicative manner and structured and accurate way of working, you approach your tasks proactively and see yourself as a competent interface in all regulatory matters for your different contact partners.
  • Cultural diversity excites you - You already worked in an international business environment and are able to adapt to cultural characteristics easily.
  • You are fluent in spoken Korean and English and preferably German and can easily create reports and texts in these languages.

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

Contact us

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.

Your contact

Julia Kirchhof
+49 2204 8306 2430

Miltenyi Biotec B.V. & Co. KG
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany

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About Miltenyi Biotec B.V. & Co. KG

Miltenyi Biotec ist ein 1989 gegründetes international operierendes Biotechnologieunternehmen mit Hauptsitz in Bergisch Gladbach bei Köln. Mehr als 3.000 Mitarbeiter entwickeln und produzieren innovative Produkte für die Zellforschung, die über Niederlassungen im Ausland und zahlreiche Distributionspartner weltweit vertrieben werden. Unser Portfolio umfasst Produkte...
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