DQS Medizinprodukte GmbH | Germany | 61xxx Bad Vilbel | Permanent position | Full time / Home office | Published since: 09.10.2026 on stepstone.de
Project Lead Regulatory Affairs (m/f/d)
Required. Competent. Dynamic: So we understand the DQS medical devices, us and the services for our customers. We are pooling our expertise in the certification and notification of management systems and products for the medical industry in healthcare, health care and medical product safety. We are part of the international DQS group with around 1,000 employees, for which more than 2,500 top-qualified and experienced auditors are in use. Our core competencies are the implementation of tailored certification audits and assessments. Future-oriented topics such as sustainability, security and quality are at the focus. This means that we are one of the world's leading providers with the aim of setting new standards for reliability, quality and customer orientation with our highly qualified team at any time. Project Lead Regulatory Affairs (all genders)
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Your tasks • Your profile • What we offer
Assessment of changes to products and QM systems, SSCPs, PSURs, and Vigilance, as part of continuous monitoring. Supporting a customer base from the medical device industry and creating the respective audit programs and sample plans, allocation of resources, verification of applications, classification, coding, etc. Participation in conformity assessment procedures, in particular in complex or novel medical devices. Professional exchange with internal and external experts (e.g. clinical experts, risk assessors). Support for government requests, if necessary Participation in inspection by ZLG, DAkkS, and SCC.
Complete studies in a relevant field (e.g. medical technology, biomedicine, engineering, natural sciences). Multiannual professional experience (> 4 years) in the development, production, testing or quality assurance of active or non-active medical devices. Deep knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP documents, as well as other regulatory requirements, MDCG guidelines and product standards. Ability to assess complex technical and clinical circumstances. Current knowledge of German and English in word and writing. High degree of self-responsibility, objectivity and professional communication.
Why us? A powerful and sympathetic team awaits you, a collegial, systematic training and interesting opportunities for further education. In addition, we offer you an attractive, performance-related remuneration, the opportunity to actively contribute and develop, as well as modern working conditions in an international environment. Hybrid Work: Office and Remote Flexible working hours Job ticket JobRad 30 days off Investment income
Location
 | DQS Medizinprodukte GmbH | |
| 61118 Bad Vilbel | ||
| Germany |
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