Regulatory Affairs Manager (w/m/d) Design Control

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Ansprechpartner
Dilsâd Babayigit
+49 (0)89 7263 210 – 00
babayigit@ageneo.de
Branche
Medizintechnik
Berufsfeld
Regulatory Affairs
Region
Bavaria

DAS UNTERNEHMEN

Currently we are looking for a Regulatory Affairs Manager (m/f/d) for our Biopharmaceutical client in Bavaria. In this exciting role you will have a focus on combination products, where you will act as a regulatory affairs expert for all medical device related aspects. You will coordinate all design control activities and at the same time be an interface to all involved stakeholders. 

IHRE AUFGABEN

  • Responsible for the coordination and execution of design control activities
  • Interface with external and internal stakeholders 
  • Review and approve relevant documents, risk-assessments, specifications, etc.
  • Liaise with the clinical department for the design of human factor studies
  • Support, development and implementation of the life cycle for combination products
  • Contact person for notified bodies
  • Ensure regulatory compliance 

IHR PROFIL

  • Degree in natural sciences (biology, biotechnology, pharmacy, chemistry or equivalent)
  • Several years of professional experience in the medical device sector
  • Experience with drug-device combination products is a plus
  • Proactive work ethic, ability to work in a team and independently are required
  • Language: Fluent written and spoken English required, German language skills are desirable
  • Confident handling of MS-Office

BENEFITS

  • high impact role 
  • excellent work and company culture 
  • flexibility and additional social benefits