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)
ID:22511
Einsatzort:Frankfurt am Main
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:
- egree 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
Frau Andrea Cindric
Da Vinci Engineering GmbH
Hauptstätter Straße 149
70178 Stuttgart
+49 711 72240 107
job@davinci.de
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EZV Regulatory Affairs Manager (m/f/d) in Frankfurt am Main Arbeitgeber: Da Vinci Engineering GmbH
Da Vinci Engineering ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in München nicht nur spannende und internationale Projekte bietet, sondern auch eine kontinuierliche Gehaltsentwicklung und zahlreiche Corporate Benefits. In einem dynamischen Team mit flachen Hierarchien fördern wir eine Kultur der Wertschätzung und Motivation, die es unseren Mitarbeitern ermöglicht, sich sowohl fachlich als auch persönlich weiterzuentwickeln.
Kontaktdaten:
Da Vinci Engineering GmbH Recruiting-Team
