🩺 Triga Consulting sucht Regulatory Affairs Spezialist (m/w/d) - Medical Device in Stuttgart

Stichworte

• Regulatory Affairs
• Medical Device
• MDR
• ISO 13485
• Technische Dokumentation
• Stuttgart
• Homeoffice
• Engineering

Zusammenfassung

Triga Consulting GmbH & Co. KG sucht einen Regulatory Affairs Manager (m/w/d) im Bereich Medical Device in Stuttgart. Die Position umfasst die Erstellung und Aktualisierung technischer Dokumentationen, die Sicherstellung der Einhaltung regulatorischer Anforderungen und die Definition regulatorischer Strategien. Geboten werden eine Festanstellung mit 35 Stunden pro Woche, 35 Urlaubstage und die Möglichkeit zum Homeoffice. Der ideale Kandidat verfügt über Erfahrung im Regulatory Affairs-Bereich für Medizinprodukte und Kenntnisse in ISO 13485 und MDR.

Benefits und Qualifikationen

• 35 Urlaubstage
• Flexible Arbeitszeiten
• Karriereperspektiven

Stellenausschreibung

Our client, a global leader in cutting-edge surgical technology, is seeking a REGULATORY AFFAIRS MANAGER (m/f/d) to join their team in the south of Stuttgart. This is a fantastic opportunity to contribute to the development and distribution of innovative medical devices worldwide.

• Homeoffice: 50%
• Details: permanent position - 35 hrs. per week – 35 vacation days per year

Aufgaben

• Prepare and update technical documentation for medical devices, ensuring compliance with MDR 2017/745.
• Guarantee adherence to all applicable regulatory requirements.
• Develop test plans, manage testing procedures, and define critical test characteristics and equipment.
• Generate standard test reports to demonstrate compliance with relevant norms and standards.
• Serve as the primary point of contact for notified bodies during technical documentation reviews and address regulatory inquiries from development and production teams.
• Define and implement effective regulatory strategies for medical device approvals.

Qualifikation

• Completed degree in engineering or natural sciences.
• Proven professional experience in Regulatory Affairs for medical devices.
• In-depth knowledge of ISO 13485 and MDR regulations.
• Excellent German (C1) and English language skills, both written and spoken.
• Exceptional coordination and organizational abilities.

Benefits

• Unlock new career paths and receive comprehensive consulting for your RA career advancement.
• Secure positions that perfectly align with your skills, knowledge, and professional goals.
• Access exclusive job opportunities with detailed company background information.
• Enhance your application documents and receive intensive interview preparation.
• Gain direct access to key decision-makers and negotiate the best possible compensation package.