Cookies are stored on your computer after visiting websites in order to ensure that your preferences are remembered, the visitor behavior on a page is registered.
We use the following types of cookies:
functional: your preferences are stored so that the use of our website is facilitated.
analytical: the use and identity of the visitors of our website (eg visited pages, used keywords and demographic data) are stored so that we can continue to improve them. This data is never shared with others.
Below you will find an overview of all the cookies that we use. When there is a change on our website, it may happen that cookies are added or expire. We will therefore regularly renew this page, so that it is always up to date.
Chrome
For information on how to customize the Chrome browser, click the button below.
Wij
doen er alles aan om u zo snel mogelijk te helpen.
U bent reeds
aangemeld met het ingevoerde e-mailadres.
Uw e-mailadres is
bekend bij ons, maar u staat op niet-actief in de ontvangstlijst. Wij hebben u een bevestigingsmail met een
activeringslink gestuurd om uw account weer actief te maken en de nieuwsbrief in de toekomst te ontvangen.
U bent aangemeld
voor de nieuwsbrief en ontvangt een bevestigingsmail op uw ingevoerde e-mailadres met daarin een
activeringslink die u dient te volgen om uw aanmelding te bevestigen. Het kan enkele minuten duren
alvorens u deze e-mail ontvangt.
Thank you for contacting us!
You will receive an email with your provided data.
Regulatory Affairs Manager Medical Devices (40 h p/w)
Geleen
What will you work at?
As Regulatory Affairs Manager you ensure that products comply to all legal obligations, the wishes and requirements from the customer and the quality requirements of the organisation. In order to guarantee this, you will study the variety of products of our customers and you implement national and international directives and guidelines.
You will advise customers during the development of Medical Devices in accordance with EU (MDR) and / or FDA guidelines and regulations, where applicable.
You will take care of preparation of technical files, submission of technical files to the notified body and maintenance of the technical files during their life cycle.
You will act as the Person Responsible for Regulatory Compliance (PRRC) in accordance with the MDR
You will communicate both completely and in a timely manner with those directly involved in the development and registration process for Medical Devices.
What do you bring?
A minimum of 5 years of experience with Regulatory Affairs and / or Quality Management systems relating to medical devices.
Decent knowledge of EU- and FDA guidelines and regulations in the field of Regulatory Affairs
Decent knowledge of the content of technical files in relation to class I, IIa, IIb and III medical devices.
Knowledge about MS Word, Excel and (preferrably) MS Projects
Decent verbal and written knowledge of the English language
An accurate, independent, responsible, result-oriented mindset
Education
MSc education or higher with at least 5 years of experience with Regulatory Affairs and / or Quality Management systems relating to Medical Devices. We encourage the development of our employees by offering (external) courses and training.
The offer
A challenging position where your own input is highly appreciated
A competitive salary
Good secondary employment conditions, among which remote work and flexible working hours
Dynamic and inspiring working environment in an ambitious, rapidly growing organisation
Chrome
Firefox
Internet explorer
Safari
