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Associate MDR Specialist

Job description

Associate MDR Specialist   (12 month contract)

Be part of one of the largest medical device companies globally and work on vigilance and compliance projects for the future regulations in medical device, playing a vital role in NPI and NPD projects.

Responsibilities:

  • Co-ordinate complaints for various product lines and organise and update Regulatory and QA documentation
  • Work with the Quality and Regulatory department to determine the root cause of complaints and product issues
  • Assist with risk management activities including risk analysis of products and also health hazard analysis within post market surveillance
  • Contribute key ideas and recommendations for the drug and medical device surveillance program by assisting with protocol development, process improvement and following up on adverse reports to resolve any legal or compliance projects
  • Act as an intermediary between Quality, Regulatory and Manufacturing regarding compliance to MDR and other regulations onsite
  • Ensure maintenance and accurate reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies
  • Help with standardizing and internationalization of new products
  • Will work on resolving CAPAs

 Requirements: 

  • Level 8 Bachelor’s degree within engineering with 1 year or more experience in a highly regulated medical device or related environment
  • Must have strong communication and teamwork skills

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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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