Regulatory Affairs & Quality Assurance Specialist - Netherlands
- 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.
- 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.
- 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.