EZV Regulatory Affairs Manager (m/f/d)

Da Vinci Engineering GmbH; Frankfurt; Vor Ort; EUR 65.000 - 95.000; Vollzeit

Benefits dieser Stelle

Da Vinci Corporate Benefits

On-the-job training and language课程

Continuous salary development

Zusammenfassung

Da Vinci Engineering GmbH in Frankfurt am Main sucht einenEZV Regulatory Affairs Manager (m/w/d). Sie bearbeiten EU-Zulassungen für Class III-Medizinprodukte und steuern den regulatorischen Lebenszyklus CE-zertifizierter Produkte.

Sie arbeiten eigenständig, koordinieren Projekte mit internen und externen Partnern und beraten cross-funktionale Teams während Entwicklung und Markteinführung. Idealerweise 1–3 Jahre Regulierungserfahrung, MDR-Kenntnisse und fließendes Englisch.

Qualifikationen

• Degree in Life Sciences, Pharmacy, Chemistry, Medical Engineering, or a related field.
• 1–3 years of experience in Regulatory Affairs in the medical device industry.
• Solid knowledge of EU MDR and the European regulatory framework.
• Experience with CE marking, technical documentation, and regulatory submissions.
• Strong project management, organizational, and problem-solving skills.
• Able to work independently and manage multiple priorities across functions.
• Fluent business English with excellent communication and stakeholder management.

Aufgaben

• Prepare and submit conformity assessments and clinical trial applications for EU Class III medical devices.
• Compile, review, and maintain CE technical documentation and clinical trial dossiers.
• Manage the regulatory lifecycle of CE-marked products, including renewals and annual updates.
• Coordinate communications with Notified Bodies and competent authorities.
• Assess regulatory impact of changes and provide recommendations.
• Support cross-functional teams with regulatory guidance during development and commercialization.
• Develop and implement regulatory strategies coordinating projects with partners.

Kenntnisse

Regulatory affairs

Project management

Cross-functional collaboration

English communication

Ausbildung

Degree in Life Sciences or related field

Tools

CE marking process

Jobbeschreibung

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)

ID:22511

Einsatzort: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:

• egree 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

Frau Andrea Cindric

Da Vinci Engineering GmbH

Hauptstätter Straße 149

70178 Stuttgart

[phone]

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