Regulatory affairs specialist

BioTalent; Tübingen; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

An international medical device company in Tübingen is looking for a Regulatory Affairs Specialist to ensure compliance with MDR and international regulations. You will be involved in supporting submissions, maintaining documentation, and collaborating with cross-functional teams. A strong background in regulatory affairs and fluent German is required. This position offers a hybrid work model and opportunities for long-term career development.

Leistungen

Permanent contract with long-term development prospects

Opportunity to contribute to a growing company

Direct reporting line to senior leadership

Qualifikationen

• Experience in Regulatory Affairs within the medical device industry.
• Knowledge of MDR and international regulatory frameworks.
• Fluent German is mandatory.

Aufgaben

• Support regulatory submissions and approvals for medical devices.
• Maintain technical documentation ensuring compliance.
• Monitor regulatory changes and advise on their impact.

Kenntnisse

Regulatory Affairs Expertise

Strong Communication Skills

Proactive Mindset

Jobbeschreibung

Overview

Regulatory Affairs Specialist – Medical Devices

Tübingen, Germany | Hybrid | Permanent

We are currently seeking a Regulatory Affairs Specialist to join a leading international medical device company. This is an exciting opportunity to play a key role in shaping regulatory processes and ensuring compliance within a growing global organization.

Involvement in a diverse portfolio of surgical instruments.

What this role offers you

• Opportunity to work with an established and internationally recognized medical device company
• Permanent contract with long-term development prospects
• Hybrid working model, with headquarters in Tübingen
• Direct reporting line to senior leadership, ensuring your voice and expertise are heard
• A chance to contribute to a company experiencing continuous year-on-year growth

Responsibilities

• Supporting regulatory submissions and approvals for medical devices in compliance with MDR and other international regulations
• Maintaining technical documentation and ensuring compliance across product portfolios
• Collaborating closely with cross-functional teams including R&D, Quality, and Clinical Affairs
• Monitoring regulatory changes and advising on their impact to business strategy
• Acting as a regulatory contact point for both internal stakeholders and external authorities

Your profile / Qualifications

• Experience in Regulatory Affairs within the medical device industry
• Knowledge of MDR and international regulatory frameworks
• Strong communication skills and ability to collaborate with global teams
• Fluent German
• Proactive mindset with attention to detail and problem-solving ability

If you’re ready to take the next step in your regulatory career with a growing and innovative medical device company, we’d love to hear from you.