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.

Engineer as Regulatory Affairs Manager m/f for instruments

Your role:

  • Reporting to the Regulatory Affairs Manager in R&D Engineering you coordinate and manage the conformity assessment procedures of our biotechnical instruments (including medical devices)
  • In your role you actively support our projects and prepare the technical documentation together with our project teams in order to obtain certification and international approvals for our instruments
  • Through your experience with the relevant legal requirements as well as guidelines and standards, you are independently responsible for providing regulatory support for the development and maintenance of our instruments
  • You monitor regulatory compliance in close collaboration with R&D Engineering, Regulatory Affairs, Production, Quality Assurance and Quality Control
  • You develop and provide regulatory strategies, support our customers by creating Product Information Files and maintain existing certification and approvals

Your profile:

  • You are a highly energetic, self-driven, and dedicated professional with an advanced degree in engineering, preferably mechanical, electrical or medical engineering
  • You have several years’ experience in Regulatory Affairs and you know the European and ideally the global legal requirements and related standards for instruments including but not limited to machinery, electromagnetic compatibility. Experience with ISO 9001 and ISO 13485 are beneficial
  • You have excellent written and oral communication skills and the ability to excel in a matrix, while working in a fast paced team based work environment. You are committed and see yourself as a competent partner in all regulatory relevant matters
  • Ideally, you possess strong analytical skills and you have earned experience in project management as well as working in cross-functional teams
  • You are fluent in German and English and proficient in using MS Office, Outlook, Windows Operating System Internet explorer and web applications

 

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

Benjamin Malik
+49 2204 8306 2430

Apply now

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 2,300 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 GmbH
Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany
www.miltenyibiotec.com/jobs