Jobbeschreibung
At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.
- Ensure compliance with reporting obligations for medical devices to Competent Authorities, adhering to various country-specific regulations such as Regulation (EU) 2017/745 (Medical Device Regulation, MDR) and UK Medical Device Regulations
- Collect notifications regarding complaints on medical devices, make informed reportability decisions and coordinate appropriate actions to address these issues
- Coordinate timely responses to information requests from Competent Authorities, ensuring all inquiries are handled efficiently
- Notify non-Olympus legal manufacturers about potential safety-relevant complaints received from the market for further assessment and gather additional information upon request, if applicable
- Develop and implement process improvements in alignment with new internal and external requirements, ensuring continuous compliance and efficiency
- Clearly explain and justify reportability decisions during audit situations, demonstrating thorough understanding and adherence to regulatory requirements
- Provide comprehensive reports of ongoing activities to management upon request, ensuring transparency and informed decision-making
- Participate in other ad-hoc duties and projects as required, contributing to the overall success of the organization
- University degree in engineering, medical field or a comparable professional technical qualification gained through relevant practical experience
- Solid understanding of regulatory requirements and quality management systems, including the EU Medical Device Regulation (MDR), ISO 13485 and FDA regulations (21 CFR Parts 820, 803, 806)
- Practical experience with vigilance reporting and complaint handling preferred
- Experience in monitoring and evaluating safety data for medical devices, including reporting serious incidents to the relevant authorities a plus
- Strong analytical skills and keen attention to detail in assessing compliance and safety issues
- Strong self-confidence, with the ability to make well-informed decisions and communicate and defend them effectively
- Business fluent in English; German is an advantage
- 30 days of annual leave
- Up to 60% mobile work possible and 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