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

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