Regulatory specialist
Boule Medical AB / Civilingenjörsjobb / Stockholm
2023-05-05
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hela Sverige Visa alla jobb hos Boule Medical AB i Stockholm Boule Diagnostics AB är ett globalt diagnostikbolag som utvecklar, tillverkar och säljer system och förbrukningsvaror för blodcellräkning (hematologi). Bolaget riktar sig främst till små och medelstora sjukhus, kliniker och laboratorier samt till andra diagnostikbolag inom såväl human- som veterinärhematologi. Verksamheten bedrivs genom rörelsedrivande dotterbolag i Sverige, USA, Mexiko och Ryssland. Försäljning sker globalt, företrädesvis via distributörer med stöd av Boules egna lokala säljare och servicepersonal. Boule Diagnostics aktie är sedan 2011 noterad på Nasdaq Stockholm.
We are expanding our QARA team and are now looking for a Regulatory specialist!
If you are looking for an exciting new role in a changing environment where you get to be part of shaping a strong QARA department, then read this!
This role is a full time employment and the primary location is Spånga, Stockholm.
The role will be mainly concentrating on the following areas:
• Plan and perform vigilance activities, e.g., authority contacts, recalls, advisory notices etc.
• Communicate with Notified Body and authorities regarding substantial system changes and new product designs
• Review design dossier/technical file and labeling for regulatory approval at new designs and change managements
• Keeping list of applicable laws and regulations updated
• Ensure that processes needed for regulatory compliance in the quality management system are documented
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Participate in new development projects to perform review of device-specific and region-specific regulations applicable for the new device
• Participate in projects related to entering new markets to identify applicable and necessary region-specific regulations and approvals
Who You Are
We are looking for a person who can be trusted with meeting deadlines and takes accountability and responsibility for your work, is pro-active with a positive can-do attitude, and solution oriented if there are needs to improve the way of working.
Ideal candidate for this position
• Experience within regulatory area and/or technical documentation for medical devices
• Familiar with applicable product standards in the field of IVD
• Good knowledge of medical device registrations
• Fluency in the English language and is comfortable communicating in Swedish, in speech and in writing
On top of being part of a great QARA team in an important and fun role we can offer a friendly environment with great employee benefits! Selection takes place continuously so send in your application right away!
If you have any questions related to the role or the life at Boule, kindly connect with responsible department manager Niklas Lundqvist at
niklas.lundqvist@boule.com or HR at
HR@boule.se.
Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-05-24
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Boule Medical AB (org.nr 556128-6542)
Jobbnummer 7739897
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