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Product Compliance Assistant (m/f/d) Medical Devices

Ratingen, NRW · Biotech/Pharmaceutical
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 in Ratingen near Düsseldorf we are currently looking for a
 
Product Compliance Assistant (m/f/d)
Medical Devices




Your Responsibilities:
 
  • Initiation, collection, and coordination of information of regulatory documents for various purposes
  • Preparation and maintenance of product technical files for CE marking
  • Organization and preparation of documents for international submissions
  • Conduct research about new regulations and guidance documents
  • Assist and support the Product Compliance QA/RA Manager & CE-Coordinator
  • Organize, update, and maintain regulatory documentation in accordance with department and company procedures
  • Assist with evaluating product compliance to applicable regulations and project requirements
  • Maintain and audit information with a high degree of accuracy and discretion
  • Organize and prioritize large volume of incoming correspondence
  • Communicating with suppliers, manufacturing sites, QA divisions and authorities
  • Supports other functions to ensure quality improvements


Your Profile:
 
  • Commercial education
  • Minimum of 3-years’ experience with majority in a product safety or regulatory affairs
  • Strong interest in regulatory affairs, regulations, guidance’s required
  • Proficient with computer and standard software programs (Microsoft Office, Adobe Pro)
  • Excellent organizational, time management, and administrative skills
  • Basic know how especially in the field of MDR & IVDR would be helpful
  • Excellent command of written and spoken English and German is mandatory


The offer:
 
  • Work with a top employer
  • Good development possibilities
  • Attractive salary and good social benefits
  • Exciting & challenging position
  • International work environment

  
Please use our online-application form 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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