Medical Device Regulatory Specialist

2 days ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €118,500 - €143,000
Job Summary

The role of Regulatory Affairs Specialist is crucial for the post-market activities of medical devices, supporting departmental regulatory processes and procedures, strategies, authoring, reviewing, and supporting global registrations.

Main Responsibilities:

  • Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations, and industry standards.
  • Key Deliverables: Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF, and vigilance reports to Notified Bodies, EMA, and other global competent authorities.
  • Conduct global Post-Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in our portfolio.
  • Collaboration: Support medical device EU importation requirements as Importer in accordance with Article 13 of MDR, working closely with cross-functional teams.

About this Role:

This position requires a strong understanding of regulatory frameworks and the ability to develop effective strategies for OUS medical devices and combination products. The successful candidate will be responsible for ensuring compliance with global regulations and standards, while also providing high-quality support to cross-functional teams.

We Offer:

A dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.



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