Freelance Quality And Regulatory Manager
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 Noord-Brabant Netherlands.
They are an innovative Dutch company that develops and produces a diverse line of medical devices.
ROLE DESCRIPTION
As a freelance Quality and Regulatory manager you will support the innovation services organization and develop its role as a service provider and supplier to manufacturers of medical devices. You will advise and support projects and departments to realize compliance with the Plns management system. This to accomplish specific customer requirements for the management system and realization process.
This project will be full time for 9 months, on site.
RESPONSIBILITIES
You will manage and maintain the Plns management system (MSIS) to retain compliance to applicable standards. As well as Facilitating development projects to achieve compliance.
• Clarifying customer requirements for quality assurance
• Risk assessment sessions
• Prepare management review meetings
• Develop and conduct training programs
• Establish and maintain procedure instructions and documentation.
• Give advice on the policies regarding inspections of notified bodies / competent authorities
• Communication to Q&R aspects
REQUIREMENTS
• A minimum of +-7 years of relevant working experience in medical devices
• Widely experienced with working in projects
• Design and change control processes in medical devices
• ISO 9001 and ISO 13485 experience
• Knowledge of quality controls needed for medical device manufacturing
• Up to date knowledge of law and regulations (FDA’s 21CFR820, MDD/IVDD/AIMDD directives) and harmonized standards (ISO 14971, IEC 62366,
IEC 62304) and interpretations related those regulations and standards
• Knowledge of record control
• Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rombout van Rees.
