Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist - (6-Month Contract)

? Flemish Region, Belgium (Hybrid)

A global MedTech organisation operating in the diagnostics and women’s health space is looking for a Senior Regulatory Affairs Specialist (IVD) to support its growing Regulatory Affairs function across the EMEA region.

This 6-month contract will focus on supporting high-priority product registration projects, helping ensure efficient and compliant market access for innovative diagnostic products.

Key Responsibilities

• Define and maintain product registration plans aligned with business priorities and timelines.
• Identify and establish regulatory requirements for product registrations and notifications across selected countries in EMEA region
• Lead and support product registration projects in EMEA region, including initial market entries.
• Compile and manage regulatory documentation and submission packages for distributors and manufacturers.
• Provide regulatory input to support commercial activities, market access and geographic expansions.
• Respond to IVDR and regional regulatory queries from internal stakeholders.
• Support new product introductions and cross-functional business initiatives.
• Review and approve promotional materials to ensure regulatory compliance.
• Contribute to the continuous improvement of regulatory processes and SOPs.

Your Profile

• 5+ years of Regulatory Affairs experience within the life sciences industry
• Strong experience in IVD regulatory affairs and product registrations
• University degree in life sciences or a related discipline
• Experience managing multi-country regulatory projects and cross-functional stakeholders
• Strong analytical, organisational and problem-solving skills
• Ability to communicate complex regulatory concepts to non-regulatory stakeholders
• Fluent in English; additional languages are an advantage