Regulatory Affairs and Quality Assurance manager

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 Utrecht Netherlands.

This international player has an extensive portfolio containing various types of Medical Device products. Their standards are dedicated to high technological development and innovation. They are present on the European, Asian, African and Middle Eastern market. Currently, they are experiencing a continuous growth which creates new positions.

ROLE DESCRIPTION

In your role as Quality Assurance and Regulatory Affairs manager, you are responsible for a team of ambitious quality and regulatory experts. You will become part of a dynamic and innovative business setting. On a daily basis you are responsible for overviewing the Quality and Regulatory strategies and procedures. You will be involved with international procedures and market strategies involving the European, Middle Eastern, and Asian market. In collaboration with your team, you will make sure that the QMS is compliant and that all required documentation is controlled, involving variations of legislation for particular product specifications. You will assist in creating company strategies and exchange your knowledge across other departments within the company. This role for interim manager can be filled for 6 months with the opportunity for extension to a year.

RESPONSIBILITIES

On a daily basis your major job is to overview the QA and RA team, in which you guide your team members and collaborate to improve the Quality and Regulatory department. Furthermore, you are involved with:
• Overviewing and improving the Quality Management System
• Taking the lead in creating an international regulations strategy involving CE-marking, product specifications and related legislation, and particular
evaluations
• Ensuring compliance for product launches and product registrations for existing and new markets
• Involvement and participation in development of business plans in which a regulatory point of view is required
• Establishment and maintenance of relationships with departments and external stakeholders on a global level
• Involvement and handling of customer complaints, and performing effective CAPA management

REQUIREMENTS

• Master in Life Sciences
• Minimal 7 years of experience within the Medical Devices industry
• Minimal 6 years of experience within a Regulatory Affairs role
• Excellent knowledge of ISO 13485 and relevant Medical Device regulations
• Experience in the maintenance of Quality Management Systems including Quality and Process Validation
• Excellent communicator and capacity to establish relationships
• Fluency in Dutch and English
• Used of working in a dynamic and continuously changing business setting

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.