Regulatory Affairs Officer

At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.brDo not wait to apply after reading this description a high application volume is expected for this opportunity.brGuided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking forbrJob descriptionbrDepartment InfobrTerumo Quality, Regulatory Vigilance Department, operating from Leuven, Belgium, provides regulatory affairs and post-market surveillance support to Terumo’s internal and external customers across EMEA.brJob SummarybrAre you passionate about healthcare and regulatory compliance? Join Terumo as a Regulatory Affairs Officer, where you will play a key role in ensuring our medical devices meet European, Middle Eastern and African regulatory requirements. Reporting to the Regulatory Affairs Director, you will be part of a close-knit team working together to navigate complex regulatory landscapes and maintain product approvals.brYour responsibilities will include supporting regulatory services for product registration and reviewing labelling and promotional material to ensure the accuracy of product information and alignment with applicable legislation and standards.brIf you are detail-oriented and eager to make an impact in the medical device industry, we would love to hear from you.brJob ResponsibilitiesbrPrepare and maintain product registration files.brDevelop, maintain and supervise product registration files for products manufactured and/or sold by Terumo Europe.brReview labelling and promotional material.brEnsure that multilingual product labelling and instructions for use for Terumo products comply with European and national regulations, in cooperation with the relevant Terumo Europe departments and Terumo affiliates.brReview product information (brochures, leaflets, website) to ensure it is not in conflict with information available in the technical documentation.brBuild knowledge of regulations.brClosely follow and monitor new developments in European medical device regulations.brClosely monitor legal and regulatory issues related to medical devices at national level across EMEA.brMaintain the systems implemented for medical devices in compliance with European regulations, including CE marking and safety requirements, and with MDSAP requirements where applicable.brAssist in implementing new systems or amending existing systems to comply with regulations outside EMEA and in MDSAP countries whenever required to support the business.brProvide support to local offices on regulatory issues.brEnable the business.brSupport tender-related activities: Provide regulatory affairs information for tender processes and customer enquiries.brProfilebrA university degree in science, preferably with a medical or pharmaceutical focus, or an equivalent qualification and experience in a scientific environment such as clinical research or biochemistry.brExperience in regulatory affairs in the medical device and/or pharmaceutical field is not required but is an asset.brGood working knowledge of English, both written and spoken. Knowledge of Dutch is an advantage.brAccurate, self-disciplined and well organised, with strong multitasking and communication skills and the ability to collaborate effectively within the department and across functions.brYou live in Belgium and can commute easily to the office in Leuven.brOfferbrYou will join an international Regulatory Affairs environment where you will play an active role in monitoring regulatory developments, driving their implementation and helping to ensure compliance across the organisation.brYou will join a passionate Regulatory Affairs team whose members will support you as you further develop your skills. xlxgzvr brWe offer an environment that puts quality products and care for patients and healthcare professionals at its heart, together with a competitive salary and benefits package.