EZV Regulatory Affairs Manager (m/f/d)

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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]