Regulatory Affairs Specialist

CellaVision is a global leader in digital microscopy, delivering complete solutions that combine advanced instruments, reagents,

and software to support healthcare services worldwide. Our vision is clear: To elevate healthcare through the evolution of

microscopy - in a sustainable way.

We work at the forefront of technology and use advances in programming, chemistry, digital imaging, and machine learning. Joining

CellaVision means playing an important role in supporting healthcare through the continued evolution of microscopy.

As a Regulatory Affairs Specialist, you will play a key role in supporting the regulatory strategy for CellaVision’s innovative

IVD products. You will drive global registration and lifecycle management activities, interpret evolving regulatory requirements,

and collaborate closely with cross-functional teams to ensure compliance and market access worldwide. Working alongside Quality

Assurance, Clinical Affairs, R&D, and Product Management, you will combine hands-on regulatory expertise with strategic support,

while contributing to the development and mentoring of less experienced colleagues.

You combine strong regulatory knowledge with a pragmatic and collaborative approach. You are comfortable taking ownership,

translating complex requirements into clear actions, and communicating with stakeholders at different levels of the organization.

You work independently when needed, while contributing actively to the team.

• Proven experience in regulatory submissions, licensing, and product registration activities for IVDs and/or medical devices in

international markets, including CE marking, FDA Submissions, Health Canada Medical Device Licensing (MDL), and other regulatory

approval processes in markets where medical devices or IVD products are commercialized.

• Inclusive, Innovative Culture: Work in an international, collaborative environment focused on executing big ideas and adding

customer value.

• Job Security: We offer a collective agreement, including comprehensive insurance, occupational pension, parental leave

supplements, and more.

• Health & Wellbeing: We support your health with free access to a gym, wellness allowance, lunch benefits, sponsored running

competitions, and discounts on gym memberships.

This is a full-time position primarily based on-site at CellaVision’s HQ in Lund, Sweden, with the flexibility to work remotely

one day per week.

Apply via our career site. We work with continuous selection and interviews, so please submit your application as soon as

possible. Applications are not accepted by email.

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.

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.