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Senior Regulatory Affairs Specialist

Job description

Senior Regulatory Affairs Specialist

Work with one of the world’s largest medical device companies as part of their ever-growing plant here in Galway where they have developed a focus for innovation and product excellence to deliver best-in-class solutions.

Responsibilities: 

  • Work as part of the wider RA team supporting NPI and NPD projects while also working on change controls for existing product lines
  • Provide technical expertise to resolve any potential regulatory issues from regulatory agencies
  • Prepare regulatory submissions for new products and product changes to ensure timely approvals for market release and clinical studies
  • Work on global recertification and compliance for labels and marketing materials
  • Prepare submissions and reports for EU and US regulatory agencies
  • Build a strong relationship with external regulatory bodies
  • Identify and implement best practices for the RA Department
  • Assist in post market surveillance support for commercial products

 Requirements: 

  • Level 8 bachelor’s degree or level 9 master’s degree in science or similar discipline
  • Must have 5 years or more in regulatory affairs or have similar experience

 

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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