Regulatory Affairs Officer

About the Role

A new opportunity for a Quality/Regulatory Affairs Officer has recently become available to work with a growing Diagnostic Company in Antrim (Northern Ireland). As a Regulatory Affairs Officer you will be working as part of a team to ensure quality and regulatory standards are met for our innovative IVD devices. Using your knowledge of ISO 13485, you will be expected to collaborate closely with your colleagues to assist with quality assurance activities in order to maintain an appropriate quality environment. This is a superb opportunity for someone looking to progress their career into the within the Medical Device/IVD sector.


Key Responsibilities

As a Regulatory Affairs Officer, you'll be responsible for:

  • Developing and coordinating programs to ensure all international registrations and licenses are completed efficiently.
  • Managing the creation and development of technical files.
  • Assuring continued compliance with regulatory requirements to maintain applicable certifications.
  • Ensuring that all procedures and controlled documents are introduced and any subsequent changes to existing documents are made according to an agreed standard with full records kept in accordance with the Quality Management System requirements such as ISO 13485.
  • Controlling and maintaining the Company document management and filing systems.
  • Hosting internal audits and liaising with notified bodies.
  • Ensuring compliance with EU regulatory requirements.
  • New submissions and renewals.


Your Skills and Experience:

  • Experience in Medical Device or Healthcare industry.
  • Degree in a life science or equivalent.
  • IVD Directive (98/79/EC).
  • Regulatory submission for medical devices.
  • Experience in internal auditing ISO 13485 requirements.
  • Class I, II, III medical devices.
  • Good planning and organisational abilities.
  • Must have the ability to communicate effectively with management and fellow peers.
  • Pro-active with proven ability to work under own initiative, and strong team player.


Reward

  • Competitive salary
  • Health & wellbeing plan
  • Corporate Perks card
  • Free car parking

Apply Now

To apply for this role, please send your CV to Rosita Zolnourian at rosita@fortressdiagnostics.com.

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