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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