Regulatory Affairs Manager IVD to Q-linea

Q-linea continues to grow and is now looking to recruit a Regulatory Affairs Manager IVD to join the company. Q-linea develops and delivers innovative solutions for the diagnosis of infectious diseases, with a keen focus on improving sepsis treatment while reducing antibiotic resistance. The company’s leading product, ASTar®, is a fully automated instrument for antimicrobial susceptibility testing (AST), which produces a sensitivity profile from a positive blood culture in approximately six hours. This is 24 to 40 hours faster than current diagnostics.
As a Regulatory Affairs Manager, you will have a key role in the Clinical study team and help bring about a new reality of faster phenotypic AST that allows healthcare providers to accurately diagnose and treat infectious diseases in the shortest possible time. In this role, you will have the opportunity to contribute to studies to gain CE mark and FDA clearance for new products. We are looking for an outgoing clinical trial regulatory expert, who wants an exciting position at a company in the forefront of innovative infectious disease diagnostics.

Q-linea has its HQ in Uppsala Sweden and is listed on the Nasdaq Stockholm Mid Cap. The position is full-time and preferably based in Stockholm or Uppsala, Sweden. We welcome your application today!


About the position
As a Regulatory Affairs Manager IVD, you will be part of the Clinical Study team inside the Clinical Value Department at Q-lInea and report directly to Chief Medical Officer (CMO) at the company.
Duties and responsibilities include:
• Act as a clinical trial regulatory expert for the Clinical Value department.
• Prepare and manage study protocols and study related documentation related EU clinical trials in compliance with IVDR, ISO 20916 “In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice”, and ISO 20776-2 “Evaluation of performance of antimicrobial susceptibility testing devices”.
• Prepare independently FDA pre-submissions and lead communication with FDA about planned applications.
• Assist the Clinical Study Leader with the development of clinical trials plans and their execution, with support from local Regulatory Affairs/CRO partners.
• Support the Clinical Study Leader with the preparation of SOPs related to trial organization and management
• Participate in the preparation of trial budgets
• Stay updated on the relevant procedures linked to the role


Your profile
The suitable candidate has the following qualifications:

- BSc or higher (MSc, PhD) degree within Life Sciences
- Multiple years’ experience in working on Regulatory affairs studies within the in vitro diagnostics space in Europe and in the USA.
- Prior experience of preparing independently pre-submissions to FDA
- Prior experience with 510(K) submissions.
- Fluent in English, both written and oral
- Clinical trial regulatory expertise

The ideal candidate for this position is result-driven, well organized and has a strong ability to work in a team. Strong communication and time management skills as well as a high level of accountability are required to be successful in this role. Furthermore, we believe that you are a “quick on your feet” and have an eye for details.
If you are ready to bring your skills and expertise to this position, we are ready to offer you an exciting and dynamic work environment where you will make a key difference and help patients get better clinical outcomes!


About the organisation
Q-linea AB is a public-listed diagnostic company focused on developing and delivering solutions to enable healthcare providers to diagnose and treat infectious diseases in the shortest possible time. Our vision is to help save lives by, as an innovative pioneer, ensuring that antibiotics can be maintained as an effective treatment for future generations. The company was founded in 2008 around technology developed by researchers from the Rudbeck Laboratory at Uppsala University, together with Olink Bioscience AB and Uppsala University's holding company UUAB. Q-linea today consists of a 100+ interdisciplinary and highly motivated team that conducts its operations in modern and well adapted premises in Uppsala Science Park and in Fyrislund. You can find more information about Q-Linea at www.qlinea.com