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Expert in Regulatory Affairs & Quality Assurance

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Expert in Regulatory Affairs & Quality Assurance

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 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

Quality and Regulatory Affairs are set at a high standard and accuracy within this well-known multinational. On a daily basis you are involved with regulated standards, compliancy and you are overviewing developments and necessary changes within the QMS. In your role as Quality and Regulatory officer, you are responsible for a particular system of the organisation. You are in charge of tracking and being fully aware of all changes within the regulatory domain for Europe and the US. This project is set for 4 months with a possibility for extension to 6 months.

RESPONSIBILITIES

A major task within your daily routine is to overview and maintenance the compliance of the set standards in relation to required legislation. Furthermore, your tasks include:
• Creating awareness of importance RA and QA within the corporate organisation by using internal resources
• Controlling and assessment of promotion materials with relevant documentation and product specifications
• Management and control of QMS documentation and reviewing these documents
• Taking the lead in organizing internal and external audits, guiding the process from the beginning to the end
• Collecting and creating reports of outcomes from audits especially for CAPA’s
• Interaction and communication with both internal and external stakeholders concerning product launch and regulations
• Providing advice and support to management in set up of QA/RA processes

REQUIREMENTS

• Bachelor in Life Sciences
• Minimal 3 years of experience with QA on a production site within the Medical devices industry
• Minimal 2 years of experience with the FDA and CE marking within Medical Devices industry
• Excellent knowledge of maintaining and improving Quality Management Systems
• Basic understanding of the differences in medical device legislation from other continents
• Fluency in English, and good understanding of the Dutch language
• Great eye for detail and strong analytical skills
• Broad knowledge of Lean-six sigma procedures
• Team player

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.

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SIRE Life Sciences®

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