Manager Quality & Regulatory Affairs (m/w/d)


Minimum qualifications

  • BS degree in engineering, life sciences or similar technical field of study or equivalent practical experience.
  • At least 2 years of experience in quality management or regulatory affairs in the medical industry or a similar environment.
  • Excellent team player with extensive communication and problem-solving skills.
  • Working proficiency and communication skills in verbal and written English and German.

Preferred qualifications

  • Master’s, PhD degree, further education or experience in engineering, computer science or other technical related field.
  • Experience with one or more applications including but not limited to: PLATO SCIO, Q-DAS qs-STAT, Q-DAS solara.MP.
  • Understanding of GMP, MDR & ISO 13485:2016 principles and requirements.
  • Interest and ability to learn as needed.


  • Manage individual project priorities, deadlines and deliverables as well as external consultants.
  • Create and test SOPs according to GMP, MDR & ISO 13485:2016.
  • Monitor the CE conformity process according to MDD & MDR.
  • Prepare and execute internal and external audits.
  • Plan and conduct trainings.
  • Participate in product development projects.

MK-dent GmbH Recruitment
Marie-Curie-Straße 2 22941 Bargteheide


Unternehmen: MK-dent GmbH

Art der Beschäftigung: Stellenangebot

Befristung: Unbefristet

Bereich: Medizintechnik

Einsatzort: Schleswig-Holstein, Bargteheide

Beginn: 26.07.2022

Wochenstunden: Vollzeit


MK-dent GmbH

Ansprechpartner: Florian Kleene


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