Global IVD Regulatory Lead

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, 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.