Medical Devices JobsRegulatory Affairs Specialist

  • SJ51699
  • Permanent
  • Offaly

Collins McNicholas

My client, a well-established company in the healthcare industry, is looking to hire a Regulatory Affairs Specialist to join their growing company. This is a new and exciting role! The ideal candidate will have 1+ years of experience in regulatory affairs, quality or documentation and will have a relevant qualification in science, engineering or quality.

Responsibilities: (full job description available on request)

  • Create and maintain audit friendly product file for customers and HPRA assurance
  • Analysis of product compliant or non-compliance with regulatory requirements
  • Research of alternative EU based suppliers
  • Evaluate changes to manufacturing and supply chain processes
  • Approve product labels, package inserts and marketing material

Requirements:

  • A minimum of a degree in a Quality/Engineering/Science or related discipline is a MUST
  • At least 1 years’ experience in a medical device/healthcare industry in a regulatory or quality position
  • Must have very strong Technical Writing ability
  • Must have good understanding of ISO 13485 and FDA QSR quality standards
  • Excellent verbal and written communication skills
  • Excellent attention to detail skills
  • Must have the ability to work on own initiative, be able to work to targets and also as part of a team

For a confidential discussion and more information on the role, please contact Niamh Cregg.

071-9149732

niamh.cregg@collinsmcnicholas.ie

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