Regulatory Affairs & Quality Assurance Specialist

The 37Company is looking for a:

Regulatory Affairs & Quality Assurance Specialist

Organisation
The 37Company 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. 

Our products

Your responsibilities

  • Be the RAQA responsible for main Product Group: Fluido® and Fluido® Compact products
  • 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 37Company, headquartered in Amersfoort
  • 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

Are you interested? 

Please send your resume and motivation letter to sollicitaties@the37company.com
After a pre-selection process, you can receive an invite for (face-to-face) business interviews.
 

Acquisition is not appreciated.