Global Regulatory Affairs Director

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Holland Netherlands.

The Company

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

In your role as director you will become part of a dynamic and innovative business setting. You will be responsible for a team of 10 people. Your main responsibility lies in the development and implementation of a RA strategy that is applied on an international level. You will overview the department and ensure that you and your team are fully up to date with international legislation and regulatory affairs involving European, American and Asian markets. Furthermore, you are also involved with other departments and external stakeholders which you will advise on particular issues. This project lasts for 8 months with a possibility for extension to a year.

Responsibilities

Your main responsibility lies in overviewing your team that is dedicated to the controlling and implementation of legislation and required documentation. Furthermore, you are involved with:
• Offering guidance regarding risk assessment and CAPA’s in order to meet the regulatory standards
• 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
• Guiding and leading a team consisting of 10 regulatory affairs experts

Requirements

• Master in Life Sciences
• Minimal 12 years of experience within the Medical Devices industry
• Minimal 6 years of experience within a Regulatory Affairs role
• Proven experience in a leadership role with a minimum of 8 team members
• Excellent knowledge of FDA, MDD and Chinese regulations
• Experience in working with class l and class ll products
• Excellent communicator and capacity to establish relationships
• Fluency in Dutch and English
• Used of working in a dynamic and continuously changing business setting
• Well prepared to travel frequently across the globe

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.