Collins McNicholas

Role Summary:

Lead activities within the EU Authorised Representative function for the Vision Care business of the organisation.


Role Responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland for the organisation
  • Deputise for the Regulatory Affairs Manager for all regulatory body communications
  • Provide EU Regulatory subject matter support to Vision Care business for key projects and activities
  • Serve as the person responsible for regulatory compliance for the EU Authorised Representative

EU Authorised Representative

  • Develop and maintain a good knowledge of the Vision Care product portfolio
  • Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer
  • Maintain the Authorised Representative registration with the Irish competent authority and maintain product registrations for Vision Care products.
  • Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN)
  • Field questions from the competent authorities regarding product performance and/or vigilance and recall on the EU market
  • Work with the legal manufacturer to provide responses to questions
  • Participate in notified body and competent authority inspections of Vision Care legal manufacturer and manufacturing sites
  • Manage the process for provision of certificates of free sale for Vision Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalisation
  • Upgrade the Authorised Representative policies, procedures etc for compliance


Regulate Subject Matter Expertise

  • Support key MDR work streams
  • Contribute to discussions internally and with notified body and competent authorities
  • Willingness to travel to company business 10-15% of time


Role Requirements:

  • Minimum bachelors’ degree in an engineering or scientific discipline or a Masters’ degree in regulatory affairs or a related discipline
  • 4-5 years’ experience in regulatory affairs


For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email

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