EZV Regulatory Affairs Manager (m/f/d)

EZV Regulatory Affairs Manager (m/f/d)

Stellen-ID: 22511

Standort: 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:

• 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