European Regulatory and Quality Affairs Manager 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
 

European Regulatory and Quality Affairs Manager for Medical Devices (m/f/d)

 

Your Responsibilities:

  • In this role you will be responsible for leading and overseeing the European programs in the areas of Regulatory Affairs, Quality and Compliance for medical devices (e.g. X-ray, IVD, Healthcare IT, Endoscopy)
  • Develop, deploy, maintain and oversee a fully compliant and efficient company-wide Quality Management System for all European entities
  • Develop, deploy, maintain and oversee the following fully compliant and efficient company-wide programs:
    • Regulatory Affairs program
    • Corporate Compliance program
  • Represent the Regulatory and Quality Affairs function and provide regulatory and Quality guidance and strategy to the parent company and give European wide regulatory and Quality affairs support for local European companies
  • As the Medical Devices Regulations (MDR) Project leader in European Medical Systems Division, ensure the company’s Medical Systems Division, entities and dealers are compliant with MDR
  • Act as medical regulatory and Quality affairs representative for European and German regulatory authorities, external partners and in-house functions
  • Act as Safety Officer for medical devices and organizing incident reporting and execution of Field Safety Corrective Action (FSCA)
  • Keep strong relationships with Industry associations and organizations
  • Report to the company worldwide headquarters and Senior Management level of European Medical Systems division

 

Your Profile:

  • Bachelor of Science Degree
  • 10 or more years of executive leadership experience, building, leading and maintaining a Global Regulatory, Quality and Compliance program in the medical device industry
  • Deep knowledge of European Medical Device Directive and Medical Device Regulations and international standard requirements (ISO 13485/ISO9001, ISO 14971, IEC 62304, FDA regulations and guide lines)
  • Comprehensive knowledge of European international premarket and post-market regulatory requirements
  • Strong knowledge of Corporate Compliance laws and regulations
  • Excellent leadership, communication, collaboration, team work and interpersonal skills
  • Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external)
  • Excellent talent assessment skills
  • Strong ability to multi-task and to meet business deadlines
  • Excellent organizational skills with an ability to think proactively and prioritize/deploy work
  • Organization and planning skills
  • Project management, presentation, communication, negotiation and interpersonal skills
  • Written and conversational fluency in professional English is required. Proficiency in German is favourable
  • Team spirit and cross-cultural awareness

 

The offer:

  • Permanent role with a top employer that offers very good development possibilities
  • Attractive salary and very 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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Sara Eskafi
+49 911 590 596-44
Germany
 
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