QARA Manager

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 Antwerpen Belgium.

With a leading market position, the company has made his mark in the development of products in different industries. With their medical devices division, they have been successful in providing hospitals and other healthcare providers with high-end systems and devices available on the market.

ROLE DESCRIPTION

As the QARA Manager, you will be responsible for the compliance of all the devices to the currently applicable regulations and standards. You will set up, follow up and maintain the Quality System, as well as take care of all the Regulatory Affairs in the best way possible. You will also have activities on a global level, and be in contact with lots of different stakeholders. If you love to work with an ambitious team, and you’re looking for a challenging career, this might just be the right job for you!

RESPONSIBILITIES

You are responsible for the quality improvement strategy of the company’s medical device division
You are responsible for the creation and the approval of different procedures and policies, such as ISO 13485 and ISO9001, concerning the Quality System in the division
You manage the QARA specific processes in the company
You will have to keep the organisation updated with regional regulations and quality standards, concerning the medical devices and software they produce
You are responsible for planning and coordinating external regulatory audits, and execute internal audits as well
You will deal with product registrations and regulatory submissions
You will follow up concerns of customers that question the quality of the products
By participating in health and medical device regulation events, networking will be a big part of your work, in order to have a clear overview of today’s trends
You will be the direct point of contact between senior management and your team

REQUIREMENTS

You have studied for a Master degree in engineering, computer science or something equivalent
You have a long background in a regulatory environment and quality system activities
Earlier experience in medical devices and/or pharmaceuticals is a big advantage
Your knowledge of quality standards and regulatory affairs are very profound and up-to-date (ISO 13485 and ISO 9001)
You are proficient at MS Office like Word, Excel, etc.
You are able to correctly interpret and translate existing and new regulations/standards to communicate them to the concerning people in the company
You are very proficient in English
You are good at analytically thinking
You can motivate people easily and make them ready for future challenges to achieve general business goals
You have a very organised way of working, in which you aim for the best outcome at all times

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Nicolas Gyselinck.