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.
Drive the implementation and management of R&D offshoring in EMEA by coordinating offshore technical capabilities, aligning them with core R&D needs, and promoting collaboration with global and regional stakeholders.
- Create and update Instructions for Use and other user information for medical devices in accordance with company standards and specifications
- The work on Instructions for Use can include both New Product Development and general sustaining
- Coordinate approval workflows with the relevant internal teams
- Supervision of document localization (translation management) and supervision of creation of illustrations
- Selection, guidance and communication with external service providers
- Act as interface to R&D Sustaining Team, Product Management, R&D, Regulatory Affairs, UX-team and other internal stakeholders
- Ensure a high document and process quality in collaboration with all departments
- Bachelor's or Master's degree in a Technical Communication, Technical Writing or equivalent professional education
- First professional experience in Technical Communication, preferably in medical device industry
- Confident handling of DTP programs (such as Adobe InDesign)
- Basic skills in graphic programs to create illustrations (such as Adobe Illustrator/Photoshop)
- Experience in working with XML-based content management systems desirable
- Experience in sustaining regulated devices under Design Control (21 CFR 820), ISO 13485, ISO 14791, MDR and knowledge of applicable regulations for the Technical Communication area such as IEC 82079-1 and ANSI Z535
- Proficient communication skills in written and spoken English
- Strong collaboration skills
- 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