Regulatory Affairs Expert

2 days ago


Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €120,000
Job Overview

We are seeking a highly skilled Regulatory Affairs Expert to join our organization.

Key Responsibilities
  • Develop and implement regulatory strategies to obtain and maintain regulatory approval for medical devices in target markets.
  • Lead design reviews in compliance with internal procedures and EU and FDA requirements, including maintaining design history files and managing the filing, storage, and retrieval of quality records.
Requirements
  • Excellent understanding of global medical device regulations, particularly in accordance with FDA guidance and the Medical Device Directive (MDD 93/42 EEC).
  • Proven ability to develop and implement effective regulatory strategies, ensuring compliance with company and regulatory requirements.
Benefits

The ideal candidate will enjoy a comprehensive benefits package, including a competitive salary, excellent benefits, and opportunities for career growth and development.



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