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Specialist in Regulatory Compliance

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time
Regulatory Affairs Specialist

The role of the Regulatory Affairs Specialist is crucial in ensuring that all products distributed by our client meet and exceed internal and external regulatory standards, contributing to the company's commitment to long term success.

  • Identify if products are compliant or non-compliant with all regulatory requirements within the current market and cooperate with non-complaint potential suppliers.
  • Manage regulatory changes connected to UKCA and MDR and monitor changing or evolving global regulations.
  • Ensure all products and paperwork are audit ready for customers, HPRA assurance, WHO inspections and supplier audits.
  • Lead strategic quality improvement projects that strengthen the company's long-term success.
  • Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
  • Managing assessments of any device/quality systems changes.
  • As the ISO Quality Management representative, manage all correspondence with Notified Body to achieve certification.
Required Skills and Qualifications
  • A minimum of 3 years' experience in a regulatory position within the medical device industry is essential.
  • Qualification in Regulatory Affairs is essential.
  • The desired candidate will be a self-starter and be able to operate with minimal supervision.
  • Strong knowledge of ISO, MDD, MDR & CE/UKCA.
  • A strong sense of time and task management and have excellent attention to detail.
  • Have a systematic way to review processes and be capable of leading change and continuous improvement.

Our company values innovation and collaboration. If you have a passion for regulatory affairs and a desire to drive excellence in your work, please consider applying for this exciting opportunity.