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Regulatory Affairs & Quality Assurance Specialist - Netherlands  

The 37 Company (company)


Posted on : 05 May 2017

Project Description

  • Our company is a leading European company acting on a global level in the field of hypothermia and offering a complete range of innovative solutions for Patient Temperature Management. The core business is all about 37°C, about keeping patients at a constant healthy body temperature. 

Your responsibilities  
  • Be the RAQA responsible for a main Product Group; 
  • Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field); 
  • Review development quality reports and plans to ensure that the information required for submissions is adequate; 
  • Plan, generate, and coordinate regulatory submissions for product/solution licensing; 
  • Facilitate and/or review communication towards suppliers, critical subcontractors and customers; 
  • Audit finished product suppliers and critical subcontractors; 
  • Maintain existing regulatory filings/licenses, managing updates and related change control processes; 
  • Provide input for the resolution of complaints and non-conformities; 
  • Release finished products, improve existing processes; 
  • Assist the Director RAQA with other activities. 

Do you have the profile we are looking for?  
  • Three years of experience in the Medical Device industry and preferably in auditing; 
  • Bachelor’s (Higher Vocational Education) or Master degree in a preferable technical discipline; 
  • Familiarity with preparation and submission of 510(k), registration and listing at FDA; 
  • Working knowledge of medical device regulations like 93/42 EEC, 21CFR 820 and preferably other country specific MD regulations; 
  • Working knowledge of standards: ISO 13485, ISO 14971 and preferably IEC 60601-1 series and ISO 10993 series; 
  • Excellent organizational skills, effective time management, ability to identify priorities and manage multiple tasks; 
  • A positive, self-motivated, pro-active and customer-oriented person with good interpersonal, communication and influencing skills; 
  • Fluent in written and oral English and Dutch. 

We offer 
  • A challenging full-time position (regular) within the fast growing Company.
  • We welcome you to a dynamic, ambitious and innovative working place with great opportunities for you to explore; 
  • Our benefits are: A competitive salary including a variable bonus based on both companies and personal performance and a company pension scheme.