Specialist Quality Assurance and Regulatory Affairs for Medical Devices (m/f/d)

Job Description

Our client is a successful international company known for innovation in healthcare, graphic arts, optical devices, highly functional materials and other high-tech areas with more than 30,000 employees world-wide. The company´s vision is to create an open, fair and clear workplace culture that allows to discern objective facts in a sincere and straightforward manner, make rational decisions, and continuously take on challenges with courage. For the European Headquarter of their Medical Devices business division in Düsseldorf we are currently looking for a

 

Specialist Quality Assurance and Regulatory Affairs for Medical Devices (m/f/d)



Your Responsibilities:

  • Represent the Quality Assurance and Regulatory Affairs function and assist to provide regulatory guidance and strategy to the mother companies as well as to give European wide regulatory support for company entities, distributors and dealers
  • Act as Quality Assurance and Regulatory Affairs contact person for European Competent Authorities, external partners and in-house functions
  • Work for MDR (Medical Device Regulation) project to let the company and all related sales entities to be compliant with MDR
  • Support the development, implementation and evaluation of Regulatory Affairs procedures, processes, standards and systems, evaluate bottle necks and/or compliancy risks and support the implementation of improvements
  • Report to the European regulatory authorities/contacts on time and ensure that progresses are tracked and follow up communications are provided

 
Your Profile:

  • Master’s Degree, preferably in engineering, law, chemistry, biology, medicine or related discipline or equivalent combination of education and experience
  • Interest in technology and European regulations
  • Detailed understanding of MDR/IVDR & MPG (MDD)
  • Knowledge and understanding of quality systems, processes, audit and inspections
  • Experience as Safety Officer for medical devices is a plus!
  • Organization and planning skills
  • Ability to work across cultures
  • Excellent oral and written communication skills in English

 
The offer:

  • Permanent role with a top employer
  • Very good development possibilities
  • Attractive salary and very good social benefits
  • Exciting & challenging position
  • International work environment
  • Working with the latest state-of-the-art technologies and interesting topics

 
 
Please use our online-application form (https://antalfmcg.catsone.com/careers/7875-Antal-International-Nurnberg/jobs/12670945-Specialist-Quality-Assurance-and-Regulatory-Affairs-for-Medical-Devices-mfd) only for applying to advertised position. Please note that we can´t consider applications that we receive by e-mail.
 
Do you have any questions or require further information? We are always happy to answer any enquires you may have either by telephone or by e-mail:
ANTAL INTERNATIONAL PERSONALBERATUNG
Andreas Dürr, E-Mail: aduerr@antal.com, Tel.: 0911 590 596 44
 

 
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Contact

Andreas Dürr
+49 911 590 596-44