Senior Regulatory Affairs Manager (m/f/d)

Jetzt bewerben Senior Regulatory Affairs Manager (m/f/d) Olympus Winter & Ibe GmbH (OWI) | Beschäftigungsart: Festanstellung Funktion: Standort: Hamburg Stellenreferenz: 80010389-04062025 Kontakt: Stefan Konegen Webseite: https://www.olympus-oste.eu As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions. Ihre Aufgaben – Management of registration cases for product development projects and renewals – Monitoring and interpretation of changes in official regulations with a country-specific focus – Coordination of registration activities across multiple regions and support for distributors in preparing necessary documentation – Support development of strategies for early access to market – Develop and foster strong cross-functional collaboration with key stakeholders, including R&D and regional RA counterparts – Contribution to standards boards and assessment of cost and business impact of registration cases – Presentation of regulatory topics to third parties and mentoring of junior team members on regulatory matters Ihre Qualifikationen – Diploma or Master’s degree in Engineering or a related field (or equivalent experience) – 5+ years of experience in a highly regulated industry in RA, with involvement in at least 10+ registration projects – Strong knowledge of regulatory requirements in specific markets and project management expertise – Advanced communication skills in English – Cultural awareness and the ability to adapt to diverse international markets – Exceptional self-management, organizational, and interpersonal skills – Ability to explain complex regulatory concepts to non-regulatory stakeholders and junior team members Ihre Vorteile – 30 days of annual leave – Up to 60% mobile work possible + flexible work time model with overtime compensation – Holiday and Christmas bonuses – Corporate benefits discounts for employees – Comprehensive company pension scheme and capital-forming benefits – Company restaurant with live cooking and healthy food (subsidized) – Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being – Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing – Various subsidized company sports groups and access to the inhouse company gym Jetzt bewerben Teilen: Twitter Xing