Regulatory Compliance Manager

7 days ago

Cork, Cork, Ireland beBeeRegulatoryAffairs Full time €50,000 - €80,000
Job Description

Beckman Coulter Diagnostics is a global leader in diagnostic solutions. We are seeking a Regulatory Affairs Specialist to join our team.

The successful candidate will be responsible for ensuring that quality systems aspects, such as CAPA management and global procedure review, are implemented effectively. This includes participation in cross-site Global Regulatory Affairs initiatives, product registration, IVDR document maintenance, and minor/moderate design change management for the AU Chemistry Product line.

This position is part of the Quality and Regulatory Affairs Department located in Ireland and is an on-site position. As a Regulatory Affairs Specialist, you will be responsible for providing regulatory support to local regulatory teams, customers, and commercial regulatory teams globally.

Required Skills and Qualifications
  • Bachelor's degree in a Science-related field with a minimum of 3 years' experience in QA or RA role within a manufacturing facility.
  • Excellent written and communication skills.

Previous experience in managing change effectively, understanding ISO13485, ISO9001, CMDR, MDLW, ANVISA, TGA, IVDD, IVDR, and FDA regulation requirements would be advantageous.

Benefits

This role offers flexible work arrangements, allowing you to work remotely from your home. Additional information about this arrangement will be provided by your interview team.

Key Responsibilities
  • Prepare and maintain technical files in compliance with IVD Directive and IVD regulation as applicable for the EU.
  • Act as RA representative on Design Change projects, including the development and implementation of registration strategies for new product launches.
  • Review, prepare, and compile documentation required for global regulatory submissions.
  • Support change management and perform RA support for minor and moderate design changes for the AU product line.
  • Support Global RA tasks/projects, which may include supporting RA colleagues outside of the Co. Clare site.
  • Control distribution of product from regulatory perspective through regulatory stop ship program.

The ideal candidate will possess excellent organizational and time-management skills, with the ability to work in a busy environment.

We believe in designing a better, more sustainable workforce. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

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