Regulatory Affairs expert

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.

Our client is a professional in Healthcare products and Medical Devices who operates on an international level. They are one of the leaders in technological developments and innovation. They are active within a broad range of technology-driven industries, varying from household products to healthcare devices.

ROLE DESCRIPTION

You will become part of dynamic international business setting in which you gain the responsibility to develop a vision and strategy for medical devices and related software. The regulatory affairs in relation with quality assurance are of an important matter for this organisation to maintain their position within the market. Furthermore, you are a key player who maintains relations across various departments. You will keep on track with the quality departments for clinical affairs, and suppliers. Next to that you are the person who is qualified to maintain relationships with notified bodies and submit the correct documentation both for Europe and Canada. In this position you will get the opportunity to create your own vision and develop your own tools to maintain and improve the quality by support of your team. This role if offered for 6 months and can be extended to a year.

RESPONSIBILITIES

As mentioned previously you will overview and create a vision and strategy for a procedure of the organisation’s product line and related software. Furthermore this job involves:
* Assurance of compliancy and quality within various regions, from which most important: Europe, Canada and the US, which involves different technical
files and the 510k notification
* Main lead in keeping track of latest regulatory developments on a global level, and address these developments with your team to create applicable tools
* Providing training and coaching to both internal and external stakeholders concerning RA regulated topics
* Regulate and create procedures and improvement strategies for the related affairs
* Assessment of marketing and communication strategies in relation to the product specifications and relevant legislation

REQUIREMENTS

* Bachelor Degree in Medical Science
* Minimal 6 years of experience in a RA role within a Medical Device company
* Knowledge into detail of European medical device standards, FDA 510k, and health Canada
* Fluency both in English and Dutch
* Excellent understanding of product development which involves specifications, designs and accompanied software
* Flexible and pro-active attitude to maintain relationships across the globe
* A person who sets high standards and has eye for detail

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.