Baden-Württemberg: REGULATORY AFFAIRS MANAGER (m/f/d) - Medical Device

TN Germany; Stuttgart; Hybrid; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An innovative firm in the medical technology sector is seeking a Regulatory Affairs Manager to oversee compliance and documentation for cutting-edge surgical devices. This permanent position offers a 50% home office option and generous vacation days. You will be responsible for preparing technical documentation, ensuring regulatory compliance, and acting as the main contact for notified bodies. Ideal candidates will have a degree in engineering or natural sciences, coupled with professional experience in Regulatory Affairs. Join a forward-thinking company that values your skills and offers new career perspectives!

Leistungen

35 vacation days per year

New career perspectives

Exclusive job opportunities

Optimization of application documents

Direct access to decision-makers

Qualifikationen

• Completed degree in engineering or natural sciences required.
• Professional experience in Regulatory Affairs for medical devices.

Aufgaben

• Preparation and updating of technical documentation for medical devices.
• Ensuring compliance with applicable regulatory requirements.

Kenntnisse

Regulatory Affairs

ISO 13485

MDR 2017/745

German (C1)

English

Coordination Skills

Organizational Skills

Ausbildung

Degree in Engineering

Degree in Natural Sciences

Jobbeschreibung

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Client:

Location:

Stuttgart, Germany

Job Category:

-

EU work permit required:

Yes

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Job Reference:

a9a9eb7d66dc

Job Views:

1

Posted:

10.05.2025

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Job Description:

Our client develops, manufactures and distributes cutting-edge surgical technology worldwide.
At its location in the south of Stuttgart, we are currently recruiting for a:

REGULATORY AFFAIRS MANAGER (m/f/d)

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

• Preparation and updating of technical documentation for medical devices in compliance with MDR 2017/745
• Ensuring compliance with applicable regulatory requirements
• Development of test plans, organization of testing procedures, and definition of test characteristics and equipment
• Creation of standard test reports to demonstrate compliance with relevant norms
• Acting as the main contact for notified bodies during technical documentation reviews and regulatory inquiries from development and production teams
• Defining regulatory strategies for the approval of medical devices

Qualifikation

• A completed degree in engineering or natural sciences
• Professional experience in Regulatory Affairs for medical devices
• Knowledge in the areas of ISO 13485 and MDR
• Excellent German (C1) and English language skills, both written and spoken
• Strong coordination and organizational skills

What TRIGA Offers You:

• New career perspectives and comprehensive consulting for your personal RA career
• Positions that match your skills, knowledge, and goals
• Exclusive job opportunities with background information about the company
• Optimization of your application documents and intensive preparation for interviews
• Direct access to decision-makers and negotiation of the best compensation package

YOUR CONTACT: