Technical Business Lead

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €61,238 - €90,153
Job Description

This is a permanent role that combines technical expertise with business acumen based in Cork.

Key Responsibilities:
  • Review and refine technical documentation to meet EU MDR requirements including labelling and instructions for use
  • Post finalised technical documentation and review checklists to a central repository
  • Track and report compliance metrics to the Senior Regulatory Affairs Manager
  • Evaluate and escalate EU MDR regulatory compliance gaps and potential patient safety issues to the Senior Regulatory Affairs Manager
  • Maintain and support the European Authorized Representative Quality Management System (EAR QMS)
  • Collaborate with the EMEA product registration team where necessary
  • Develop close working relationships with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product release in EU countries
Requirements:
  • Hold a Bachelor of Science degree or equivalent and have at least 4 years of work experience
Benefits:
  • Opportunity to work on complex technical projects
  • Chance to collaborate with cross-functional teams
  • Contribution to ensuring patient safety and compliance
Additional Information:

This is a hybrid role offering flexibility and autonomy while being part of a collaborative team environment.

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