Regulatory Affairs Specialist

EPM Scientific; Bayern; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A leading medical device company in Bavaria is seeking a Regulatory Affairs Specialist for a hybrid role supporting regulatory submissions and compliance activities. The ideal candidate has proven experience in regulatory affairs within medical equipment manufacturing and a strong knowledge of EU MDR and ISO 13485. This position offers a 12-month contract with an immediate start.

Qualifikationen

• Proven experience in regulatory affairs within medical equipment manufacturing companies.
• Strong knowledge of EU MDR and ISO 13485.
• Familiarity with FDA 21 CFR Part 820 is a plus.

Aufgaben

• Support regulatory submissions and compliance activities.
• Align with EU and international medical device regulations.
• Prepare and review technical documentation and regulatory submissions.

Kenntnisse

Regulatory affairs experience

Knowledge of EU MDR

Knowledge of ISO 13485

Technical documentation preparation

Detail-oriented

Jobbeschreibung

Regulatory Affairs Specialist - Medical Device Manufacturing Project (Bavaria 🇩🇪)

We're hiring Regulatory Affairs Specialists for a major medical device manufacturing project based in Bavaria! Join a leading Medical Device Company in a hybrid role supporting regulatory submissions, compliance activities, and alignment with EU and international medical device regulations.

📍 Location: Bavaria (hybrid)
📅 Duration: 12-month contract
🚀 Start: ASAP

🔍 Key Requirements:

• Proven experience in regulatory affairs within medical equipment manufacturing companies
• Strong knowledge of EU MDR, ISO 13485, and familiarity with FDA 21 CFR Part 820 is a plus
• Skilled in preparing and reviewing technical documentation, regulatory submissions, and supporting Notified Body interactions
• Detail-oriented, proactive, and collaborative professionals preferred

If you're available and interested, please send your CV along with your availability. First batch of submissions goes out today! 📤