Regulatory Affairs Professional

2 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000
Regulatory Affairs Professional Role Overview

This is a key role in the development of cutting-edge structural heart devices, working closely with cross-functional teams to ensure compliance with internal and external regulatory requirements.

Key Responsibilities:
  • Clinical:
    • Coordinate and support global clinical trial execution, including site activation, enrolment, follow-up and closure.
    • Communicate study status and timelines, escalating unresolved issues to line managers.
    • Develop study documents, including study protocols and Investigator's Brochure.
    • Maintain the clinical study electronic database and ensure accurate information is readily available.
  • Regulatory:
    • Support compliance to all internal and external regulatory requirements.
    • Review and assess changes affecting clinical investigations.
    • Prepare regulatory submissions for clinical and commercial applications.
Requirements:
  • Degree or master's degree in science or engineering, or related disciplines.
  • Experience in medical device Clinical Affairs or Regulatory Affairs preferred.
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements preferred.

The above role profile is not exhaustive. Duties, responsibilities and activities may change or new ones may be assigned over time.



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