BIOTRONIK AG, Vascular Intervention (VI), in the Swiss town of Bülach, Zürich, develops and manufactures stents and balloon catheters for the treatment of cardiovascular and endovascular diseases. We are seeking a maternity leave replacement for a period of 10 months starting August 2025 with the potential of extension for our Vascular Intervention (VI) regulatory affairs group. The regulatory affairs department is responsible for worldwide registration of the newly developed products and the existing portfolio. With newly developed class III innovative products, the Regulatory Affairs department offers a great opportunity to work on truly challenging regulatory submissions. Your Responsibilities Assessing and clarifying the requirements for new Vascular Intervention device registrations and the regulatory impact of changes. Supporting submissions by preparing and providing required documentation and deficiency responses in a timely manner to achieve registrations in assigned countries. Coordinating activities in relation to the registration of products from other manufacturers distributed by Biotronik. Maintaining project status of registrations in the regulatory database. Staying up to date with the latest regulatory requirements in the assigned countries. Your Profile University degree in natural sciences, engineering, or equivalent background. Minimum 2-3 years of experience in regulatory affairs in a medical device company operating on a global scale. Worldwide experience in the registration of high-risk medical devices (class III and IV) with a particular focus on the APAC region, with emphasis on India, China, South Korea, Taiwan. Independent, reliable, and communicative personality which is able to deliver high-quality work and handle a high number of projects simultaneously. Proficiency in Microsoft Office applications, registration databases, and SAP. Fluency in the English language is mandatory; German and any other language is an advantage. Are you interested? Please apply online through our application management system! We are looking forward to welcoming you. Location: Bülach | Working hours: Full-time | Type of contract: Limited Apply now under: www.biotronik.com/careers Job ID: 60607 | Contact: Martina Micciulla | Tel. +41 75 429 56 23
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