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Regulatory Affairs Expert

2 weeks ago

Athlone, County Westmeath, Ireland beBee Careers Full time

Job Summary

We are seeking a skilled Regulatory Affairs professional to support the development and maintenance of regulatory compliance for medical products in the EMEA region.

Main Responsibilities

  • Cordination and management of regulatory and product registration activities
  • Preparation of internal reports, change control documents, and review of documents for potential impact on global regulatory submissions
  • Preparation of product registration files for submission to global regulatory bodies/agencies
  • Participation in project work such as new product introductions, changes to existing products and processes
  • Support internal and external audits
  • Maintenance of product registration database

Requirements

  • Degree in a relevant Science or Engineering discipline required
  • 2-3 years medical device industry experience within quality or regulatory desired
  • Technical writing expertise
  • Basic knowledge and understanding of US and/or international medical device regulations, standards and guidance documents
  • Project Management skills and experience

Desirable Skills

  • Self-driven and ability to work independently and/or as a team player
  • Approachable and enthusiastic
  • Flexible and adaptable
  • Able to work on own initiative and as a team player
  • Good organisational skills with cultural awareness and sensitivity

Travel Requirements

Up to 10% travel, primarily hybrid model with occasional onsite work.