Regulatory Affairs Lead

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €120,000
Senior Regulatory Affairs Professional

We are seeking a Senior Regulatory Affairs Specialist to lead our regulatory activities including product certification and compliance.

The successful candidate will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions for required markets, and maintaining technical files for all cleared products.

Key Responsibilities:
  • Manage the regulatory and vigilance process ensuring adherence to relevant regulations and standards.
  • 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 in accordance with regulatory requirements.
  • Support the Quality team in managing any required product certification testing, audits, and risk management processes.
  • Complaints handling for medical reporting and filing to the appropriate competent authorities.
  • Keep up to date with changing regulatory and compliance requirements, identifying areas for improvement and implementing changes as necessary.
  • Maintain environmental registrations for all markets ensuring compliance with relevant regulations.
  • 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 for the company.
Requirements:
  • A third-level degree in a relevant field such as life sciences or engineering, along with significant experience in medical devices.
  • Post-graduate qualification in Quality Assurance an advantage.
  • SIGNIFICANT regulatory affairs experience including international regulatory processes, product certification testing requirements, and maintaining a certified Quality Management System.
  • In-depth knowledge of relevant regulations and standards including EN/MDD/MDR, ISO 13485, and FDA requirements.
  • Trained QMS Internal Auditor.
  • Strong attention to detail, excellent verbal and written communication skills, results orientated and a self-starter with ability to work on own initiative.
  • Promote best practice and knowledge of the QSR and ISO/MDD standards.
  • Advanced Microsoft Office and reporting tool skills.
  • Strong project management skills.

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