Regulatory Affairs Specialist

The Regulatory Affairs Team

You will play a key role in the Regulatory Affairs team, consisting of two colleagues. The Regulatory Affairs team is responsible for the registration of our products in countries where CellaVision intends to market our products, often through support or cooperation with our international distribution partners. The Regulatory Affairs team is also responsible for monitoring, interpreting, and forwarding the regulatory requirements into QMS and product requirements. This position offers a unique opportunity to take on tasks independently and to plan your activities with a great amount of freedom. You will work in close collaboration with your team and be encouraged to bring new ideas to the table to drive improvements. Thus, this will be a broad role where you will benefit from your previous background within Regulatory Affairs and have room to grow and be challenged.

Regulatory Affairs is a part of the Quality department with eight dedicated colleagues that are all passionate about quality. The Quality department is divided into three different functions; Quality Assurance, Regulatory Affairs, and Clinical Affairs supporting the global CellaVision organization.



Key tasks as Regulatory Affairs Specialist

- Manage product registrations
- Standard and regulation monitoring
- Support function for various Regulatory Affairs issues within the company
- Regulatory impact assessment for product changes
- Monitor and initiate updating of quality routines
- Perform internal audits




What can we offer you?
CellaVision has a world-leading position in digital cell morphology and we see our employees as our primary resource for our ongoing innovation and success. Joining CellaVision means that you will surround yourself with over 200 passionate and ambitious colleagues and that you will be part of developing products that do not only help patients worldwide but also contribute to reduced environmental impact through more efficient workflows in and between laboratories.



We believe you have:

- Bachelor's degree or higher university education or equivalent in a technical specialization
- Experience of work in Regulatory, Quality, QMS. If you are newly graduated, you need a strong interest in working in the Regulatory Affairs area.
- Knowledge of QSR (21CFR 820)
- Knowledge of ISO 13485
- Excellent communication and writing skills in English




Meritorious:

- Registrations of medical devices
- Vigilance reporting
- Experience from development projects and participation in new product realizations
- Experience from Med Tech




Who you are
We believe you are a result-oriented, and ambitious person, who is dedicated to achieving set goals. You are not afraid to take initiative and contribute to your team with ideas. Because the RA team is a small team, we give our colleagues both a lot of freedom but also a lot of responsibility when it comes to independent work and owning your tasks in both success and setbacks. We apply an open climate and have a close collaboration between departments, so your ability to cooperate is something we value highly. We believe you have a well-developed ability to take on complex tasks. We believe you appreciate being part of a team where we work together and share information and solutions. We also believe you are a meticulous person who organizes and prioritizes your work efficiently and who is passionate about producing high-quality work.



Are you ready to make a difference?
Join CellaVision, put your quality skills to greater use, and help us contribute to lab efficiency and improved patient value worldwide. We need your expertise to do the job!

Apply to this job by filling in the application form and attaching your CV/personal letter. Please prepare to have your documents, such as certificates, credentials, and recommendations, for a potential interview. We review applications continuously, so please send us yours as soon as possible but no later than February 25, 2022.

This is a full-time position with start as soon as possible, based at CellaVision HQ in Lund, Sweden with new offices, good infrastructure, and commuting possibilities. To know more about the position contact Magnus Johnsson, Director Quality, at magnus.johnsson@cellavision.com. Questions about the recruitment process are answered by Caroline Herrlander, HR Specialist, at caroline.herrlander@cellavision.se. We do not accept applications via email.

Please note that you need a valid working permit in Sweden for this role.

We respectfully decline all contacts regarding additional channels, campaigns, or recruitment support.