Regulatory Affairs Specialist

CellaVision; Lunds kommun; On-site; SEK 700,000 - 900,000; Full time

Benefits offered by this job

Inclusive culture

Work-life balance

Job security

Health & wellbeing

Modern workplace

Team spirit

Job summary

CellaVision, Lund, Sweden, is seeking a Regulatory Affairs Specialist to drive global registrations and lifecycle management for our IVD products. You will interpret regulatory requirements and collaborate with QA, Clinical Affairs, R&D, and Product Management to ensure compliance and market access.

You will lead regulatory submissions (CE, FDA, Health Canada, and others), monitor IVDR 2017/746, and mentor colleagues while working in a fast-paced, global team.

Qualifications

• Bachelor’s degree or higher in a relevant field (life sciences, engineering)
• Extensive hands-on Regulatory Affairs experience in medical devices or IVDs
• Experience with CE marking, FDA submissions, Health Canada licensing, and other international approvals
• Knowledge of EU IVDR (2017/746) and regulations in US, Canada, Brazil and Japan
• Excellent written and spoken English communication skills
• Structured, detail-oriented, analytical mindset with strong judgment
• Ability to work independently and with cross-functional teams

Responsibilities

• Manage product registrations and provide regulatory documentation to distributors and external partners
• Monitor regulations and standards and assess impact on products and QMS
• Promote awareness of regulatory requirements across the organization
• Provide regulatory support and guidance across teams
• Lead or support regulatory change assessments and change management
• Monitor and update quality procedures as regulatory requirements change
• Support QA/RA Manager and senior management in strategic regulatory decisions
• Participate in product development and approve relevant documentation
• Prepare, review, and sign regulatory documents within delegated authority

Skills

Regulatory expertise

Stakeholder communication

Ownership of regulatory strategy

Cross-functional collaboration

Education

Bachelor’s degree or higher

Job description

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.

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

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