OCULUS Optikgeräte GmbH | Germany | 35xxx Wetzlar | Permanent position | Full time / Home office | Published since: 07.07.2026 on stepstone.de
Product Safety and Risk Management Specialist (m/f/d)
We're looking for you! OCULUS Optikgeräte GmbH offers you various professional possibilities! We are an internationally successful family company with more than 550 employees and branches in more than 10 countries. We have been developing and producing high-precision devices and instruments for eye diagnostics for over 130 years. Always at the centre: our strong team – unique people who bundle their skills daily to achieve goals together. With solid and secure operating conditions, we offer a lot of benefits, not least through our value-adding corporate culture with a focus on trust, mutual support and individual promotion. As a specialist (gn) product safety and risk management, you can support risk analysis, product changes as well as Complaints and Vigilance topics, thereby introducing your technical qualification, knowledge according to ISO 14971 and experience in the medical device environment. You want to become part of this team? Then we have the right offer for you:
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Your tasks • Your profile • What we offer
Maintenance, development and documentation of product-related risk management and the creation and updating of risk analyses and risk management records in accordance with ISO 14971 Participation in the risk-related assessment of existing products, new developments, product changes and new product categories including follow-up of risk control measures Processing and feedback of relevant findings from Complaints, Vigilance, CAPA, PMS reviews, audits, standard changes and product changes into risk management Cooperation with interdisciplinary interface areas such as development, quality management, regulatory affairs, usability engineering, requirements engineering and external testing laboratories Support for the combination and traceability of safety-related requirements and technical documentation, in particular in the context of Polarion, RiskManager and PLM systems Participation in risk-related evidence and preparation and provision of relevant documentation for audits, audits, notified bodies and authorisation activities
Technical qualification, ideally studies in medical technology, electrical engineering, computer science or comparable discipline Good knowledge of risk management according to ISO 14971 Experience in the medical device environment and understanding of product safety and regulatory requirements Knowledge of technical documentation and product development and product changes Analytical thinking as well as independent, structured and reliable functioning Teamability, initiative as well as solution-oriented and responsible action Very good German knowledge and good English skills
Above-average remuneration, including occupational pensions, holiday and Christmas money as well as attractive employee discounts at a variety of companies Balanced work-life balance with flexible working hours and remote office option Attractive training catalogue with numerous certification options A wide range of offers in the company's health promotion programme, such as partially funded sports courses, JobRad, individual screen workstation goggles, take over the costs of certain precautionary studies and much more Bistro with healthy and freshly cooked meals at discounted costs free staff parking; good transport links also to public transport
Location
 | OCULUS Optikgeräte GmbH | |
| Münchholzhäuser Str. 29, 35582 Wetzlar | ||
| Germany |
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