Senior Regulatory Affairs Specialist

CellaVision works to advance laboratory workflow and diagnostic certainty through intelligent microscopy. We are a world leader in digital microscopy and offer a full solution including instruments and reagents. Our products are used in health care services around the globe.

We work at the forefront of technology and use many of the latest advances in programming, chemistry, digital imaging, and machine learning. Joining our company means you will play an essential role in elevating healthcare through the evolution of microscopy.

Position: Senior RA Specialist

Location: Lund, Sweden

Job type: Full Time, Permanent

How will you contribute?

You have an important role in the Regulatory Affairs team. 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. We work as a team and together we solve and divide the tasks related to registrations. 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 efficiently 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 facilitate improvements. In this role you will have room to grow and be challenged. We work close together and discuss how best to move forward in the different areas. We’re an experienced team who like working together.

Regulatory Affairs is a part of the Quality department and has in total 9 dedicated colleagues that are all enthusiastic 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 180 employees covering 32 countries.

As a RA Specialist you will:

- Manage product registrations

- Monitor directives and regulations

- Work as support function for various Regulatory Affairs issues within the company

- Perform regulatory impact assessment for product changes

- Monitor and initiate updating of quality routines

Please read more about working with our team https://career.cellavision.com/departments/quality

What will you bring?

- You have a bachelor’s degree or higher university education or equivalent in a technical specialization or law.

- You have several years of experience in Regulatory, Quality and QMS with good knowledge of QSR (21CFR 820) & ISO 13485.

- You have good knowledge of working with Microsoft Office

- Proficiency in English, both written and verbal.

What we offer?

At CellaVision, we believe that Employee Recognition, Communication & Collaboration, Innovation & Continuous Improvement enable us to develop into the very best version of ourselves. Our culture is one of teamwork, partnerships, and caring relations. We also believe in having fun together!

We offer flexible working hours and depending on the role the possibility of hybrid work. Through our collective agreement, you have substantial coverage both if you fall ill and for your retirement. It also provides a time bank for some extra time off and new parents a supplement when staying home with their small child.

We believe in having fun together and meet for breakfast on Fridays, different team activities and company festivities. Some of our engaged team members coordinate running groups, games nights and meet ‘n’ eat lunches. In our office there is a free gym as well as a parking garage for bicycles and access to showers, we also provide all our people with a wellness allowance to support a healthy lifestyle.

Ready to apply?

We work with a continuous selection so please apply sooner than later via our career site.

We do not accept application by email.

Diversity is in our blood

At CellaVision we understand not only the uniqueness of blood cells but also of people. We strongly believe in the power of diversity and recognise it as a driver of innovation. We are committed to building an inclusive culture for all our people.

CellaVision is a non-discriminatory workplace where qualified applicants receive consideration for employment without regard to race, nationality, ethnic or social origin, age, religion, political orientation, sexual orientation, gender identity/expression, family or marital status, pregnancy, disability, or any other basis prohibited by law.

More about us

CellaVision® was established in Sweden in 1994 with a vision to simplify, standardize, and digitize the manual analysis of blood cells in hematology laboratories. The company’s long-term success is a result of our commitment to innovation. Our goal is to provide value to patients, customers, and distributors by incorporating smart solutions into everything we do. Our research and development focus on offering superior analytical and diagnostic certainty by creating an ecosystem that combines reagents with hardware and software. Today CellaVision has 250 employees, with global Headquarters in Lund, Sweden.

The company has market support offices in 16 markets and a presence in over 40 countries with reagent development and manufacturing performed in Martillac, France.

For more information visit www.cellavision.com (http://www.cellavision.com)

Working together with human and artificial intelligence to advance diagnostics. - it’s in our blood.