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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job description

Regulatory Affairs Specialist

About Your New Employer

In your job as Regulatory Affairs Specialist, you will be working for a Medical Device manufacturer based in Galway City. In your new job you will be working with devices used to save and enhance lives. 

About Your New Job

  • You will prepare regulatory submissions to regulatory authorities within the EMEA region.
  • As Reg Affairs Specialist, you will assist with determination of regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • You will participate on various teams to define regulatory requirements for countries in the EMEA region, and process international submissions.
  • It's your job to identify guidance documents, international standards, consensus standards and assists teams with their interpretation.
  • You will interact with various levels of management, external agencies and companies.
  • Your job is to assist with developing, maintaining and analyzing department systems and provides training when needed.
  • You will work on developing regulations and revises systems as necessary.
  • You will participate in and assists with Competent Authority inspections, Notified Body Audits and other governmental inspections as directed or as applicable.
  • You will perform other related duties and tasks, as required.

What You Need

  • A Level 8 Degree in STEM  
  • Experience working in Reg Affairs in the Medical Device industry. 
  • knowledge of the Medical Devices Directive (93/42/EEC), Medical Device Regulation (2017/745) and ISO 13485 Quality System Standard

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:

  • Fully covered Health Insurance 
  • Pension Scheme
  • Life Assurance
  • Educational Assistance 
  • Career Progression Opportunities

What’s Next

Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E:

All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent

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