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EZV Regulatory Affairs Manager (m/f/d)
Da Vinci Engineering GmbH · Frankfurt am Main, Hessen, Germany
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Nothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us! EZV Regulatory Affairs Manager (m/f/d) Stellen-ID: 22511 Standort: Frankfurt am Main We are searching intelligent and innovative employees. If you are interested in working for a dynamic company with flat hierarchy, we look forward to receiving your application. Your tasks:
- Prepare and submit applications for conformity assessments and clinical trials for Class III medical devices within the EU
- Compile, review, and maintain CE technical documentation and clinical trial dossiers to ensure regulatory compliance
- Manage the regulatory lifecycle of CE-marked products, including renewals, change notifications, and annual updates
- Coordinate communications and responses to Notified Bodies, Competent Authorities, and other regulatory stakeholders
- Assess the regulatory impact of product, manufacturing, and process changes and provide recommendations accordingly
- Support cross-functional teams by providing regulatory guidance throughout product development and commercialization
- Develop and implement regulatory strategies while coordinating projects with internal and external partners Your profile:
- Degree in Life Sciences, Pharmacy, Chemistry, Medical Engineering, Bioengineering, or a related scientific discipline
- 1–3 years of experience in Regulatory Affairs within the medical device industry
- Solid knowledge of EU Medical Device Regulations (MDR) and the European regulatory framework
- Experience with CE marking, technical documentation, and regulatory submissions
- Strong project management, organizational, and problem-solving skills
- Ability to work independently, manage multiple priorities, and collaborate effectively across functions
- Fluent business English with excellent communication and stakeholder management skills You can expect ...
- Experience in exciting and international projects
- Continuous salary development
- Da Vinci Corporate Benefits
- On-the-job training and language courses
- Appreciation, motivation and commitment Kontaktdaten für Stellenanzeige Frau Andrea Cindric Da Vinci Engineering GmbH Hauptstätter Straße 149 70178 Stuttgart +49 711 72240 107 [email protected]