Regulatory and Quality Engineer – Medical Device

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.