Your Role:

  • Within the Regulatory Affairs team you are responsible for the worldwide approval of all Miltenyi Biotec’s devices for clinical and research markets regarding environmental guidance
  • Therefore you will support the R&D department to develop instruments accordingly to fulfill the essential requirements as local/international standards including environmental regulations
  • You are experienced in applying standards e.g. DIN EN ISO 13485, EN ISO 62304 „software life cycle process“; MDD, 21CFR820 but also environmental obligations as RohS, WEEE and working with the FDA
  • You provide leadership and build partnerships across all levels of the organization to foster environmental management improvement and to ensure regulatory compliance with Federal, State and Local regulations
  • You will lead and instruct environmental management training courses and ensure all required training is completed to staff members in the R&D engineering department
  • You will develop and implement strategic action plans to achieve the company goal of regulatory compliance and ensure timely risk assessments and adequate controls for environmental management processes

Your Profile:

  • You have successfully completed your scientific degree (for example in Engineering / environmental management / life-sciences) and several years working experience in the field of Regulatory Affairs
  • You have proven competences in leading and implementing environmental management programs, Risk Management and Medical Device certification, etc.
  • You bring along a strong knowledge of environment and quality regulations/standards and are well experienced with RoHS, WEEE, ISO 13485
  • You are committed to solutions and results and bring a proven ability to manage projects to milestones within timeline, quality requirements and budget
  • You are naturally communicative and have the ability to work with all levels of the organization as well as external agencies

What we offer:

  • Flexible working hours for a family-friendly career
  • Personal and professional development in our in-house academy
  • Intercultural and cross-border collaboration
  • A modern workplace and a role you can help shape
  • Short communication lines and a collegial company culture

Who we are:

  • Our innovative solutions in the area of biomedical research and biomedicine make us a pioneer for the therapy of serious diseases
  • Today we are an interdisciplinary team of about 2000 employees
  • Based in Germany near Cologne and with 14 additional, international locations we are a multicultural team
  • We develop innovative cell and gene therapy solutions – together, we want to make cancer history

Contact us:

Miltenyi Biotec GmbH
Benjamin Malik
Senior HR Specialist | Talent Acquistion
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Phone: +49 2204 8306-2430
www.miltenyibiotec.com