SIRE 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 companyOur client is a professional Medical Devices organization, based in Noord-Holland Netherlands. They are a Medial company focused on the development and innovation of effective health products in order to improve health and help consumers improve general health problems. They distribute globally and are now in urgent need of a QA/RA specialist. They are an ambitious and dynamic company offering challenges and opportunities offering competitive terms of employment.
Role descriptionYou will focus on all QA and RA tasks and help the company stay compliant with all ISO standards. They are behind on schedule due to the current manager being sick and are therefore looking for a new specialist who can manage and take all responsibilities as tasks over permanently. You will be involved in product development and registration strategies and projects.
ResponsibilitiesYour responsibilities and tasks as the QA/RA Manger will be:
• Responsible for RA: Preparation, registration and maintenance of CE Technical Files. You will work towards QA conformity for Medical Devices (MDD 93/42/EEC, ISO 13485, FDA)
• Leading all Regulatory and Quality activities and being compliant with the QMS and company quality policy and (inter)national registration
• You will work proactively to build and maintain a network with the Notified Bodies and other parties and authorities
• Carry out the internal and external audits at suppliers and potential suppliers
• Monitoring and reporting quality related issues
Requirements• A minimum of 8 years of experience with at least 4 years of experience earned in consumer Health and/or Medical Devices
• Proven work experience in Medical Device RA and QA and ISO 13485
• Must be capable of developing and implementing RA strategy and managing the complex negations with Regulatory Authorities
• Experience in R&D is a big plus
• Fluent in Dutch and English