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Senior Regulatory Affairs Officer

Senior Regulatory Officer- Diagnostics- Limerick
                                                                            
Our client a leading diagnostics company have the requirement for a Senior Regulatory Officer who will provide ongoing support to the regulatory team and to all teams with regulatory and legal requirements. This role will report into the Quality Manager.

Key Responsibilities:

  • Ensure employees understand their duties/delegated tasks
  • Assist in the IVDR project, representing regulatory team on cross-functional team
  • Represent the regulatory team on all new product development and change control to ensure device is compliant to appropriate regulatory requirements
  • Review all project documentation across multiple projects and final sign off as regulatory representative
  • Ensure all deadlines are on target/met
  • Prepare and maintain IVDR compliant technical files utilising information from cross functional teams for IVD Products (class a – d)
  • Track and control all regulatory submissions for product changes or renewals for device certification
  • Coordination of risk management activities and documentation for CE-IVD marked products
  • Approve labelling (labels, instructions for use) for compliance with applicable regulatory requirements and international standards, including UDI
  • Review complaints for regulatory reporting for CE-IVD marked products
  • Prepare reports for the Quality Manager/Senior Management as required

 
Education and Experience:

  • BSc in Molecular Biology or a relevant discipline.
  • 3 to 5 years’ experience working in a Medical Device or In Vitro Diagnostic Company
  • Excellent communication and interpersonal skills
  • Ability to manage competing priorities in a fast-paced environment
  • Strict attention to detail in all aspects of the role
  • Ability to work to tight deadlines

 
 

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Job Details

Limerick
7 December 2023
Job ID: 8960

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