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Regulatory Affairs Officer

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Regulatory Affairs Officer

Regulatory Affairs Officer

31 Jan 18 Belgium Biomedical Engineering

Materialise is a dynamic international high-tech company, founded in 1990 and headquartered in Belgium, with over 1,500 employees worldwide. Materialise's mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D Printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

Regulatory Affairs Officer

Responsibilities

As the Regulatory Officer, you are responsible to obtain the necessary registrations and market clearances for our medical solutions. Based on a list of priorities agreed with the business unit, you will work to meet the regulatory requirements to do business: you will analyse the applicable regulations, define product registration strategies and work together with a wide range of teams to generate and review product documentation to ensure a timely market access for our medical solutions. You will be responsible to follow-up changes in regulations that affect our medical solutions.

Furthermore, you are involved in regulatory operations projects: in line with our Year Plan, you contribute to the team efforts to implement new concepts that shape the regulatory landscape. These include the EU Medical Devices Regulation, the organization of Clinical Evaluation, medical device labeling activities, etc. You report to the Regulatory Affairs Manager.

Requirements

* Master level in science, engineering or equivalent.
* Prior experience in regulatory affairs or medical devices, and ideally both.
* You have an eye for detail and are interested in technical writing.
* You master good organizational skills with a pragmatic, hands-on and flexible approach to your work.
* You are able to find a good balance between critical mindset and practical approach. You are results driven, motivated and good at coordinating multiple projects following up with internal/external stakeholders.
* You are able to work independently but comfortable working with internal/external stakeholders, an international team across various time-zones.

Materialise offers you

People are the cornerstone of Materialise and we treasure the talent, skills, and values of our employees very highly. We believe that maintaining the right environment and culture for employees is crucial for an organization's success. Therefore, we are devoted to building a global team of specialists in an open environment that favors personal growth. Programs have been put in place to keep our fair, direct company culture alive. Moreover, we proudly invest in personal development and offer challenging careers where employees are empowered to grow professionally as well as personally. You will liaise with different people throughout the organization on a daily basis and we guarantee that no day will be the same. Your effort and energy will be rewarded with a competitive salary and with extralegal advantages. In order to have a good work-life balance, we offer you flexible working hours.
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Regulatory Affairs Officer

Type d'emploi: 
Contrat fixe, durée indéterminée , Contrat temporaire, durée déterminée