Quality & Regulatory project team lead

Location: Netherlands

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 COMPANY

Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.

This international market leader within the Medical Devices industry is continuously growing. They are one of the leaders in technological developments and innovation. They are active within a broad range of industries, and focus on technology and innovation.

ROLE DESCRIPTION

As a Quality and Regulatory project manager, you will become part of an ambitious and technology driven environment. Currently a new organisational strategy has created various areas of excellence among which Quality plays a major role. Along with quality the importance of Regulatory Affairs, compliancy and auditing also increase. You will be involved with structuring and guiding of quality and regulatory activities. You will guarantee that these running processes are compliant for both the national and international markets. Furthermore, you will have a major role when it comes to suppliers by assuring their compliancy, their qualification and development. Finally, you are also involved with spreading the message and creating awareness of quality and regulatory topics. The duration of this project is estimated at a year, with a possibility for extension.

RESPONSIBILITIES

Your priority lies in overviewing and controlling the Quality and Regulatory activities. You will be coordinating and supporting the Quality department. Furthermore, your tasks involve:
• You will have a major role in the establishment and maintenance of relationships with internal and external stakeholders
• Developing strategies and creating tools for the improvement of the Quality and Regulatory procedures
• Key contact person concerning Quality Assurance and Regulatory Affairs for internal and external stakeholders across the organisation
• Creating awareness and spread of knowledge regarding QA and RA related topics and procedures
• Supportive and advisory role as team lead, and for subsidiaries of the organisation
• Overviewing the ongoing changes and points of improvement for the Quality Management System and relevant, required documentation
• Assuring compliancy, and reacting on non-conformities by taking action
• Lead and guide your team members and departments

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 6 years of experience in a Quality role within the Medical Devices sector
• Additionally 3 years of experience in a regulatory role
• Multiple years of experience as team lead within an international organisation
• Excellent knowledge of ISO 13485, risk management, FDA, MDD, and CFR
• Excellent analytical and organisational skills
• Fluency in English and good understanding of Dutch language
• Convincing , yet enthusiastic leader
• Experience in process development and improvement

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.