Senior Medical Device Compliance Specialist

2 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €68,000 - €86,000
Regulatory Affairs Specialist

Job Description:

The Regulatory Affairs Specialist will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions, maintaining technical files, and supporting quality and regulatory management.

  • Manage the regulatory and vigilance process to ensure compliance with EU, UK, and FDA regulations.
  • Prepare regulatory submissions for required markets, coordinating input from other stakeholders and tracking product clearances and certification.
  • Maintain technical files for all cleared products, including documentation of design controls, risk management, and clinical evaluation.
  • Support senior quality and regulatory managers in managing product certification testing and risk management processes.
  • Handle complaints and medical reporting, filing with competent authorities as needed.
  • Stay up-to-date with changing regulatory requirements, such as REACH and ROHS2.
  • Maintain environmental registrations for all markets.
  • Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
  • Complete internal audits and lead CE technical file audits.
  • Support quality teams in maintaining quality management systems.
  • Expert knowledge of regulatory processes for EU, UK, and FDA product clearance.
  • Working experience of regulatory processes for ROW markets and certified quality management systems.

Requirements:

  • Third-level degree and significant experience in medical devices.
  • Post-graduate qualification in quality assurance, along with experience in active medical devices, is an advantage.
  • Significant regulatory affairs experience, including international regulatory processes.
  • In-depth knowledge of product certification testing requirements for active medical devices.
  • Knowledge and application of quality tools and methodologies, including lean six sigma and TQM.
  • Experience of EN/MDD/MDR, ISO13485, and FDA requirements.
  • Trained QMS internal auditor.
  • Strong attention to detail and excellent verbal and written communication skills.
  • Results-oriented and self-starter with ability to work independently.
  • Knowledge of continuous improvement and problem-solving.
  • Promote best practice and knowledge of QSR and ISO/MDD standards.
  • Advanced Microsoft Office and reporting tool skills.
  • Strong project management skills.

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