Senior Regulatory Affairs Professional

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €80,000 - €110,000

Job Role: Senior Regulatory Affairs Specialist

Job Description

The ideal candidate will play a key role in the implementation of post-market activities, ensuring compliance with relevant Quality System procedures and Work Instructions.

This position involves coordinating the approval of Vigilance/MDR reporting as defined in each territory, supporting and leading Regulatory Post Market System improvements, and participating in the implementation of Field Safety Corrective Action plans.

Responsibilities
  • Implement PMS activities identified under Post Market Regulatory Reporting and change assessment.
  • Approve Vigilance/MDR reporting as defined in each territory.
  • Support and lead Regulatory Post Market System improvements.
  • Participate in the implementation of Field Safety Corrective Action plans.
  • Manage RA activities for Design Changes and Supplier-related changes.
  • Provide RA support to relevant Design Teams for Key Projects.
  • Manage and support trend data for regulatory reporting.
Required Skills and Qualifications

A degree-level qualification in Engineering, Science, QA, or related field is essential. A minimum of five years' experience at a senior regulatory level in the medical device industry is also required.

Additionally, a minimum of five years' experience in creating regulatory submissions for premarket approval is necessary, with technical competency in ISO13485:2016, ISO 14971, MDR 2017/745, and FDA QSRs being a prerequisite.

Benefits

This role offers a highly competitive salary, bonus structure, pension scheme, and hybrid working arrangements.

Why Apply?

This is an excellent opportunity for a motivated individual to join a dynamic team and contribute to the success of the organization.

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