Engineer Biotechnology, Medical Technology as Regulatory Affairs Manager US (m/w/d)

Miltenyi Biotec wächst weiter. Unsere Unternehmenskultur ermutigt Sie dazu, eigene Ideen zu entwickeln und Impulse zu setzen. Willkommen in einem Team, das Innovation lebt.

Regulatory Affairs Manager US (m|w|d)

Your role

  • As Regulatory Affairs Manager you are part of our Regulatory Affairs EU team located in Teterow. You actively support the registration of medical devices in US and Canada and function as a project manager together with our Regulatory Affairs US team in Boston.
  • You ensure the communication of the specific regulatory requirements and applicable standards for medical devices in US and Canada to the product introduction teams during product development, as this is crucial for the development of medical devices and clinical research products.
  • Additionally, you coordinate the German manufacturing, R&D, QA and QC departments and collect all information for the compilation of new product regulatory submission documentation for US.
  • For maintenance you review regulatory product documentation to ensure continuity and compliance as requested by US colleagues.
  • A further task is the timely coordination and collection of information for responses to deficiency letters issued by regulatory authorities, within their required timelines.
  • You further support to prepare the required documents for clinical trials for medical devices as needed.

Your profile

  • You have completed your scientific or engineering studies, preferably in the field of biotechnology or medical technology, with a Master's degree. A Ph.D. is a plus but not mandatory.
  • You have at least 5 years of experience in regulatory affairs for EU, and/or US and Canada on medical devices, in industry.
  • A profound knowledge in the compilation of regulatory documents and submission management consistent with Medical Device Single Audit Program (MDSAP) compliance is needed.
  • You have excellent organizational skills, work independently and have strong communication skills (oral and written) in English.

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.

Your contact

Lars Kersten
Tel.: 03996-158461

Miltenyi Biotec B.V. & Co. KG

Human Resources
Friedrich-Ebert-Strasse 68
51429 Bergisch Gladbach Germany

Fortschritt entsteht aus Inspiration und Neugier. Seit 30 Jahren entwickelt Miltenyi Biotec Produkte und Services, die in Grundlagenforschung, translationaler Forschung und Zelltherapie eingesetzt werden. Heute sind wir ein weltweites Team aus über 2.500 Wissenschaftlern, Medizinern, Ingenieuren, Vertrieblern und zahlreichen weiteren Spezialisten. Bei uns werden aus neuen Ideen einzigartige Produkte. Gemeinsam treiben wir mit großer Leidenschaft den biomedizinischen Fortschritt zur Heilung schwerer Erkrankungen voran.

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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 1.700 Mitarbeiter entwickeln und produzieren innovative Produkte für die Zellforschung, die über Niederlassungen im Ausland und zahlreiche Distributionspartner weltweit vertrieben werden. Unser Portfolio umfasst Produkte für die biomedizinische...
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