Regulatory and Quality Engineer - Medical Device
Procella Therapeutics AB / Sjukhusteknikerjobb / Stockholm
2024-07-10
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hela Sverige At SmartWise we are developing and manufacturing a first-in-class endovascular delivery device whichenables direct tissue/organ infusions to hard-to-reach organs and tumors. Due to the unique mechanical properties and design, in animal studies, multiple infusions could be performed in extravascular tissue after exit of the vascular system, opening the door for future research into precise cell and biologic therapy delivery and repurpose small molecules for greater and safe local effects.
We are now looking for a Regulatory and Quality Engineer to join our team.
This is a fantastic opportunity for you who have been working a couple of years in the medical device field and want to develop a careertogether with a small team of experienced colleagues.
Key responsibilities
Performance of routine quality and regulatory tasks
Support of regulatory filings and submissions
Maintenance of the QMS, incl SOP updates andhandling CAPAs and deviations etc
Support of supplier qualifications
Routine monitoring of regulatory landscape
Support of internal and external audits
Practical experience
Understanding of medical device regulatory landscape (North America/EU) incl current MDR implementation, ISO13485, 21CFR
Technical documentation experience
Understanding of internal and external audits
Root cause investigations and CAPA concepts
Microsoft OS proficiency
Fluency in English is mandatory, Swedish highly preferred
Education
STEM subject or similar, Bachelor-level or equivalent.
Personal qualifications
Enjoy working in a small team anda regulated environment
Detail- and result oriented with the ability to work self-directed with supervision
A fast learner with solutions-oriented approach
An entrepreneurial mindset with a can-do attitude and the ability to adapt to change
Previous hands-on experience in regulatory filings of medical devices; experience in go-to-market as well as post-market surveillance of medical devices; additional territory experience, e.g. Korea, Japan are a merit
Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.
SmartCella is a world-leading biotech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 69 employees from more than 20 nationalities.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-12-27
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Procella Therapeutics AB (org.nr 559036-4609),
https://procella.se/ Arbetsplats The SmartCella Group
Jobbnummer 8795568