MediPac GmbH | Germany | 53xxx Königswinter | Permanent position | Full time | Published since: 12.03.2026 on stepstone.de
QM/Regulatory Affairs Manager (m/f/d)
MediPac GmbH is an owner-managed company in the field of medical devices. We develop and produce in a regulated environment and place great emphasis on structured processes and a clear quality orientation. To strengthen our team, we are looking for an experienced personality in Regulatory Affairs.
* After clicking the Read more button, the original advert will open on our partner's website, where you can see the details of this vacancy and contact information. If you need a translation of this text, after returning to our website it will be prepared and you can read it by clicking the Show full translation button.
Your tasks • Your profile • What we offer
Preparation and maintenance of technical documentation according to MDR (EU) 2017/745 for medical devices of risk classes Is to IIb Monitoring and implementation of new regulatory and normative provisions Participation in clinical reviews, post-market surveillance, reporting on vigilance Participation in CAPA, complaint and change management for medical devices Close cooperation with quality management, production, product management, sales and external service providers Participation in audits
Complete studies in medical technology, engineering, natural sciences or comparable qualification Multiannual professional experience in Regulatory Affairs area for medical devices (forced required) Knowledge of the MDR (EU) 2017/745 and ISO 13485 Experience in creating technical documentation Risk Management Knowledge Structured and independent operation Very good knowledge of German and English
A challenging role with clearly outlined tasks Fast decision-making processes in medium-sized enterprises Immediate proximity to the product Unlimited standing with a sustainable perspective and taking responsibility for regulatory requirements. .
Contact
 | MediPac GmbH | |
| Eduard-Rhein-Str. 1-3, 53639 Königswinter | ||
| Germany | ||
| show e-mail |
The text of this ad was translated from German into English using an automatic translation system and may contain semantic and lexical errors. Therefore, it should be used for introductory purposes only. For more detailed information, see the original text of the ad at the link below.
For more information read the original ad