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Principal Regulatory Affairs Lead

Job description

Principal Regulatory Affairs Lead

Due to continued expansion of our product development portfolio and innovation mandate, we are looking to add an experienced Principal Regulatory Affairs Lead to help drive our regulatory strategy and engage directly with key regulatory bodies across the globe in support of these projects.

Job requirements:

  • Manage regulatory submission timelines, identify risks and appropriate mitigations
  • Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations
  • Support CE Mark maintenance and substantial change submissions to notified body
  • Define and capture the regulatory strategy for the development project(s)
  • Co-ordinate and support regulatory reviews and meetings with EU Notified Bodies, Competent Authorities, FDA, PMDA and NMPA
  • Review and contribute to clinical evaluation reporting activities
  • Support post market surveillance reporting, annual progress reports.

  Experience:

  • Degree level qualification in engineering or a strongly related field
  • A minimum of 5 years’ relevant regulatory experience in a senior regulatory role in the medical device or pharmaceutical industry, ideally with Class IIb and Class III medical devices
  • Technical competency of ISO13485:2016, MDD 93/42/EEC, MDR 2017/745, and the FDA QSRs is a prerequisite
  • Good communication and organizational skills, computer literacy and the ability to present reports neatly and accurately is essential.

 

To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:   chloe.walsh@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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