EZV Regulatory Affairs Manager (m/f/d)

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 EUCompile, review, and maintain CE technical documentation and clinical trial dossiers to ensure regulatory complianceManage the regulatory lifecycle of CE-marked products, including renewals, change notifications, and annual updatesCoordinate communications and responses to Notified Bodies, Competent Authorities, and other regulatory stakeholdersAssess the regulatory impact of product, manufacturing, and process changes and provide recommendations accordinglySupport cross-functional teams by providing regulatory guidance throughout product development and commercializationDevelop and implement regulatory strategies while coordinating projects with internal and external partnersYour profile:egree in Life Sciences, Pharmacy, Chemistry, Medical Engineering, Bioengineering, or a related scientific discipline1–3 years of experience in Regulatory Affairs within the medical device industrySolid knowledge of EU Medical Device Regulations (MDR) and the European regulatory frameworkExperience with CE marking, technical documentation, and regulatory submissionsStrong project management, organizational, and problem-solving skillsAbility to work independently, manage multiple priorities, and collaborate effectively across functionsFluent business English with excellent communication and stakeholder management skillsYou can expect ...Experience in exciting and international projectsContinuous salary developmentDa Vinci Corporate BenefitsOn-the-job training and language coursesAppreciation, motivation and commitmentNothing provides more motivation than success. Da Vinci Engineering is highly committed to ensuring the own employees' success. Become a part of us!Nicht zögern. Gleich bewerben!Du hast Fragen zu dieser Stelle? Kontaktiere mich.Frau Andrea CindricDa Vinci Engineering GmbHHauptstätter Straße 14970178 Stuttgart+49 711 72240 [email protected]