Senior Regulatory Specialist

Job description


  • This role will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation
  • You will be responsible for development, collation and review of EU and US submissions including looking after PMAs, 510k registration and EU MDD Class III Design Dossiers and maintaining CE technical files
  • You will act as a key member of the R&D and NPI teams, developing strategy and aiding design control teams on international regulatory requirements
  • You will lead preparations and activities for FDA inspections, customer and corporate audits and ISO13485 surveillance audits
  • Performs regulatory review of product labelling and IFU, provides PMAP review
  • Lead risk assessment team, maintaining Risk Management Files using up to date PMS data. 
  • Lead Clinical Evaluation activities.
  • Assist in complaint and CAPA investigation and root cause analysis, and performance of effectiveness activities
  • Supervise regulatory and quality systems staff and carry out 1:1 meetings while also chairing project meetings



  • Third level degree in engineering or science with 3 years in a medical device regulatory affairs role
  • Comprehension of engineering principles adequate to allow participation in New Products Development and field complaint issues
  • Qualified systems lead auditor for ISO13485 and MDD compliance
  • 3-5 years in a team lead positions or in a senior role with several direct reports


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

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