Senior Regulatory Compliance Manager

3 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €60,000 - €80,000
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for managing all regulatory activities, including product certification and compliance, as well as supporting the ongoing maintenance, audit and continuous improvement of specific elements of our Quality Management System.

  • Manage the regulatory and vigilance process.
  • Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
  • Maintain technical files for all cleared products.
  • Support in managing any required product certification testing.
  • Support in managing the Risk Management process for all existing and new products.
  • Handle complaints for medical reporting and filing to the appropriate competent authorities.
  • Keep up to date with changing regulatory and compliance requirements.
  • Maintain environmental registrations for all markets.
  • Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
  • Complete internal audits as required and lead CE technical file audits.

This is an exciting opportunity for a qualified professional to take on a key role within our organization. The ideal candidate will have significant experience in medical devices and regulatory affairs, along with excellent communication and project management skills.

Key Requirements:
  • Third level degree and significant experience in medical devices.
  • Post-graduate qualification in Quality Assurance and experience of active medical devices would be advantageous.
  • 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.
  • Experience of EN/MDD/MDR, ISO13485 and FDA requirements.
  • Trained QMS Internal Auditor.

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