Regulatory Affairs Manager (m/f/d) - Sustaining

Jetzt bewerben Regulatory Affairs Manager (m/f/d) – Sustaining Olympus Winter & Ibe GmbH (OWI) | Beschäftigungsart: Festanstellung Funktion: Standort: Hamburg or Teltow (near Berlin) Stellenreferenz: 80215469-07072025 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 – Take over the coordination of sustaining activities within RA including change management, CAPA (Corrective and Preventive Actions) and Health Hazard Assessment (HHA) activities – Representing RA in HHA related meetings and CAPA Boards – Serve as RA SME for sustaining activities (operational work in product changes, CAPAs, HHAs) – Function as the primary RA contact for interactions with local HHA, CAPA, and product change teams regarding operational and process-related matters – Mentor and train RA colleagues on HHA, CAPA, and product change processes – Drive continuous improvement of RA processes related to product lifecycle activities Ihre Qualifikationen – Bachelor, Diploma or Master’s degree in Engineering or related field (or equivalent experience) – 5+ years of experience in regulatory affairs in medical device industry – Sound knowledge of global regulatory frameworks and requirements – Experiences supporting significant parts of lifecycle management activities including change management, CAPAs and/or Health Hazard Assessments – Intrinsic knowledge of QMS processes/systems and experiences in process development – Strong interpersonal skills with the ability to manage effective cross-functional working relationships and to explain complex regulatory concepts to non-regulatory stakeholders and junior team members – Enhanced English writing and communication skills in an international environment, German skills beneficial 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 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 Jetzt bewerben Teilen: Twitter Xing