Regulatory Affairs Specialist

The Regulatory Affairs Team

You will play a key role in the Regulatory Affairs team, consisting of RA manager Reza and RA/QA Specialist Johan. The Regulatory Affairs team is responsible for registration of our products in countries where CellaVision intend to market our products, often through support or cooperation with our international partners. The Regulatory Affairs team is also responsible for monitoring, interpreting and communicating the regulatory requirements into QMS and product requirements. This position offers a unique opportunity to run projects and 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 and has in total 9 dedicated colleagues that are all passionate about creating the best quality standard in the business. The Quality department is divided into three different functions; Quality Assurance, Regulatory Affairs and Clinical Affairs and have superpowers to support the global CellaVision organization of 170 employees covering 32 countries.



Key tasks as Regulatory Affairs Specialist

- Manage product registrations
- Standard and directive monitoring
- Support function for various Regulatory Affairs issues within the company
- Resource support for the Quality department for the release of systems / products
- Change management
- Monitor and initiate updating of quality routines
- Perform internal audits
- Perform audits with suppliers
- Other information in CellaVision's Quality department




What can we offer you?

As a Regulatory Affairs expert you play an important role for the expansion of the company when it comes to launching new products. You work on a global arena, and with a product that changes people’s lives. 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 170 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.

Other great things with working at CellaVision are:

- We have a friendly and open company culture in a flat organization.
- We have a modern office to boost cooperation as well as the ability to work undisturbed.
- You will get a yearly wellness grant and free access to the gym.
- You can take part in social events such as the weekly running group, board game evenings, Cella Choir, etc.
- You will get an extensive onboarding package for new employees including a visit to the lab to see our products live and an assigned mentor.


- We have flexible hours to promote work-life balance.


- You can take part in “Meet-n-eat” lunches where you get to meet new colleagues every month.


- We have collective agreements, ITP-pension, parental leave supplement, reduction of work hours etc.


Who you are

We believe you have:

- Bachelor's degree or higher university education or equivalent in a technical specialization.
- At least 2 years' experience of work in Regulatory, Quality, QMS
- Excellent communication skills
- Experience from Med Tech
- Knowledge of QSR (21CFR 820)
- Knowledge of ISO 13485
- Good knowledge of Microsoft Word
- Very good knowledge of English in speech and writing




Meritorious:

- Registrations of medical devices
- Vigilance issues (incidents and reporting)
- Experience with development projects, participated in new product realizations




As a Regulatory Affairs Specialist we believe you have the analytical skills to solve problems without missing the long-term strategies. You see logic and connections in complex information or environment and can analyze a large amount of information and make decisions based on own analyzes. You are able to identify visions and long-term goals and plan activities to achieve set goal. You also have a have a holistic approach and can contribute with new ideas. We believe you are service minded and value a good relationship with our customers above all. You have well developed relationship building skills and have the ability to coordinate and cooperate in an international environment. We believe you like taking initiative, are eager to learn and keep up to date within your profession. Finally, you have an effective mind set and are independent, like taking responsibility for your own work and drive it forward.



Are you ready to make a difference?

Join CellaVision, put your regulatory 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 attach 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 15th of January 2021.

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 Reza Kharraziha, RA Manager, at reza.kharraziha@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.