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