About this role
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]