A.I. Regulatory Affairs & Quality Affairs Director

Location: Belgium

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 Brussel Belgium.

This organisation is an international market leader developing a wide range of healthcare protection solutions for tons of people across the world. They offer a range of products varying from surgical gloves, to infection protection products. Their aim is to create optimal protection against viruses and diseases.

ROLE DESCRIPTION

In your role as Ad Interim Director, your main priorities are dedicated to Quality Assurance and Regulatory Affairs. You are responsible for overviewing and developing strategies and approaches for the European, Middle Eastern and African region. You will be mainly involved with the ISO 13485 standard and relevant documentation on both a national and international level. You are responsible for the maintenance and improvement of the Quality Management System. You will be taking the lead when it comes to audits and regulatory affairs submissions. You will be responsible for the interpretation and communication of related restrictions and regulations with internal and external stakeholders. This role is available for a year and has the possibility to be extended.

RESPONSIBILITIES

You will be coordinating and overviewing the Quality Assurance and Regulatory Affairs department. Furthermore you are involved with:
• Developing strategies and creating tools for the improvement of the Quality Management Systems
• Responsibility for overviewing and awareness of regulations and documentation
• Key contact person concerning Quality Assurance and Regulatory Affairs for internal and external stakeholders among which authorities and notified
bodies
• Establishment and maintenance of internal and external relationships
• 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

REQUIREMENTS

• Master in Engineering
• Minimal 10 years of experience in a Quality Assurance role within the Medical Device industry
• Minimal 5 years of experience with Regulatory Affairs for Medical Devices
• Evidence of experience in a senior management role
• Excellent knowledge of ISO 13485 and 9001
• Experience as lead in audits
• Extensive knowledge of FDA 510 K, Risk management ISO 14971, CAPA Management, Lean Six Sigma, 21 CFR Part 11, Technical Documentation,
Design Control, and GMP
• Fluency in French, Dutch and English
• Extraordinary leadership skills
• Great analytical and organizational skills
• Pro-active attitude and ability to motivate a team

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.