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. Location Lund, Sweden Job type Full time, permanent How you will contribute 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. Key responsibilities

• Manage product registrations and provide regulatory documentation to distributors and other external partners.
• Monitor relevant regulations and standards and assess their impact on CellaVision’s products/QMS.
• Promote company awareness of statutory and regulatory requirements.
• Provide regulatory support and guidance across the organization.
• Lead or support regulatory change assessments and change management activities.
• Monitor and initiate updates to quality procedures when regulatory requirements change.
• Support the QA/RA Manager and management in strategic regulatory decisions.
• Participate in product development projects and development activities, including review and approval of relevant documentation.
• Prepare, review, and sign regulatory documents used internally and externally within the role’s delegated authority.

What you will bring 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. We believe you have:

• A bachelor’s degree, higher university education, or equivalent relevant experience.
• Extensive hands-on Regulatory Affairs experience from the medical device or in vitro diagnostic industry.
• 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.
• Knowledge of IVDR (EU) 2017/746 as well as relevant regulations in US, Canada, Brazil and Japan.
• Excellent communication skills, written and spoken English.
• Strong communication skills, sound judgment, and high integrity.
• A structured, detail-oriented, and analytical way of working.
• The ability to work effectively both independently and with cross-functional teams.
• A service-minded and flexible approach.

What we offer - Inclusive, Innovative Culture: Work in an international, collaborative environment focused on executing big ideas and adding customer value. - Work-Life Balance: Flexible hours and reduced working hours to help maintain balance. - 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. - Modern Workplace: Enjoy a vibrant, collaborative office environment that encourages teamwork and innovation. - Team Spirit: Join us for weekly breakfasts and fun team-building activities. 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. Ready to apply? 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. 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 We decline all contact regarding services in advertising, consulting or recruitment.