Senior Regulatory Affairs Specialist 6 Month FTC

Senior Regulatory Affairs Specialist 6 Month FTC

Location: Zaventem Belgium (hybrid working)
Region: Europe Middle East & Africa (EMEA)

As a leading innovator in womens health we at Hologic are empowering people to live healthier lives everywhere every day. Our Regulatory Affairs team stays at the forefront of new changing and existing regulatory requirements leading the development and implementation of a global vision for regulatory affairs to shape our strategic and operational plans.

Join a specialised growing Regulatory Affairs function supporting innovative IVD solutions across EMEA. We are looking for a Senior Regulatory Affairs Specialist IVDs for a 6 Month FTC to reinforce our Diagnostics team and help drive several highpriority product registration projects.

This role will be key in handling a burst of registration activities getting projects off the ground quickly and ensuring compliant efficient market access.

What to Expect

• You will be a key regulatory partner to commercial and manufacturing teams.
• Liaising with Commercial Teams to define and maintain product registration plans based on business priorities and timelines.
• Identifying and establishing regulatory requirements for product registration and notification in selected geographies across Europe the Middle East and Africa.
• Leading and supporting product registration projects in the Middle East including some of the companys first projects in this region.
• Compiling regulatory documentation and data packages for distributors in close collaboration with manufacturers to support registrations and notifications across Europe the Middle East and Africa.
• Assembling organizing presenting and providing regulatory information and documentation for IVDs to support commercial activities market access and internal regulatory processes.
• Responding to queries from US-based manufacturers and other stakeholders regarding IVDR and related regulatory requirements.
• Acting as the Regulatory Affairs representative in business projects including new product introductions and geographic expansions.
• Reviewing and approving promotional materials in line with applicable regulatory requirements and internal compliance standards.
• Participating in the review and continuous improvement of standard operating procedures and other regulatory processes.
• Contributing to cross-divisional projects as required by the business.

What We Expect

• Experience: 5 years of professional experience in the life sciences industry ideally within the in vitro diagnostic medical devices sector and product registration.
• Education: A university degree preferably in a life science or related discipline.
• Languages: Fluency in English is essential; additional languages are an asset.
• Proven ability to manage projects including planning coordination and follow-up of activities especially in multi-country or multi-stakeholder settings.
• Strong analytical skills and a high level of attention to detail.
• Strong problem-solving skills with the ability to propose pragmatic compliant solutions.
• Proficiency in IT tools such as Outlook Word Excel and PowerPoint.
• Self-motivated proactive curious and eager to learn.
• Well-organised and able to work independently while collaborating effectively with cross-functional and international teams.
• Strong oral and written communication skills including the ability to communicate complex regulatory concepts clearly to non-regulatory stakeholders.

If you are excited by the opportunity to shape IVD market access in EMEA contribute to strategic product registrations and support a dynamic Diagnostics portfolio we would be glad to hear from you!

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