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
- +49 711 72240 107
- job@davinci.de
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EZV Regulatory Affairs Manager (m/f/d) in Frankfurt am Main Arbeitgeber: Arbeitsagentur
Unsere moderne Steuerkanzlei in Merseburg bietet Ihnen die Möglichkeit, Ihr Wissen und Talent in einem freundlichen und offenen Team einzubringen. Wir legen großen Wert auf ein angenehmes Betriebsklima, flexible Arbeitszeiten und vielfältige Weiterbildungsmöglichkeiten, um Ihre berufliche Entwicklung zu fördern. Bei uns sind Sie nicht nur ein Mitarbeiter, sondern ein geschätztes Mitglied, das aktiv zum Erfolg unserer Kanzlei beiträgt.
