PstrongSenior Regulatory Affairs Specialist – 6 Month FTC /strong /pbrDo you have the skills to fill this role Read the complete details below, and make your application today.brpLocation: Zaventem, Belgium (hybrid working) brRegion: Europe, Middle East Africa (EMEA) /pbrpAs a leading innovator in women’s 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. /pbrpJoin a specialised, growing Regulatory Affairs function supporting innovative IVD solutions across EMEA. We are looking for a strongSenior Regulatory Affairs Specialist – IVDs /strong for a 6 Month FTC to reinforce our Diagnostics team and help drive several high‑priority product registration projects. /pbrpThis role will be key in handling a burst of registration activities, getting projects off the ground quickly and ensuring compliant, efficient market access. /pbrpstrongWhat to Expect /strong /pbrullibr/li liYou will be a key regulatory partner to commercial and manufacturing teams.br/li liLiaising with Commercial Teams to define and maintain product registration plans based on business priorities and timelines.br/li liIdentifying and establishing regulatory requirements for product registration and notification in selected geographies across Europe, the Middle East and Africa.br/li liLeading and supporting product registration projects in the Middle East, including some of the company’s first projects in this region.br/li liCompiling regulatory documentation and data packages for distributors, in close collaboration with manufacturers, to support registrations and notifications across Europe, the Middle East and Africa.br/li liAssembling, organizing, presenting and providing regulatory information and documentation for IVDs to support commercial activities, market access and internal regulatory processes.br/li liResponding to queries from US-based manufacturers and other stakeholders regarding IVDR and related regulatory requirements.br/li liActing as the Regulatory Affairs representative in business projects, including new product introductions and geographic expansions.br/li liReviewing and approving promotional materials in line with applicable regulatory requirements and internal compliance standards.br/li liParticipating in the review and continuous improvement of standard operating procedures and other regulatory processes.br/li liContributing to cross-divisional projects as required by the business.br/li /ulbrpstrongWhat We Expect /strong /pbrullibr/li liExperience: 5+ years of professional experience in the life sciences industry, ideally within the in vitro diagnostic medical devices sector and product registration.br/li liEducation: A university degree, preferably in a life science or related discipline.br/li liLanguages: Fluency in English is essential; additional languages are an asset.br/li liProven ability to manage projects, including planning, coordination and follow-up of activities, especially in multi-country or multi-stakeholder settings.br/li liStrong analytical skills and a high level of attention to detail.br/li liStrong problem-solving skills, with the ability to propose pragmatic, compliant solutions.br/li liProficiency in IT tools such as Outlook, Word, Excel and PowerPoint.br/li liSelf-motivated, proactive, curious and eager to learn.br/li liWell-organised and able to work independently while collaborating effectively with cross-functional and international teams. xirbnpk br/li liStrong oral and written communication skills, including the ability to communicate complex regulatory concepts clearly to non-regulatory stakeholders.br/li /ulbrpIf 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! /pbrp#LI-RH1 /p