Regulatory Affairs and Quality Assurance Specialist
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Utrecht Netherlands.
Leading European company acting on a global level in the field of hypothermia and offering solutions for patient warming.
ROLE DESCRIPTION
- Be the RAQA responsible for a main Product Group
- RA is more important than QA.
RESPONSIBILITIES
- 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
REQUIREMENTS
• 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
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
