Regulatory Affairs Specialist

Posted 19 June 2023
LocationCounty Offaly
Job type Permanent
Discipline Quality & Laboratory
Contact NameDavid Rooney

Job description

What you need to know

Matrix Recruitment is working with our client, who are a healthcare distribution company to hire a Regulatory Affairs Manager to join their team in Co. Offaly.

As Regulatory Affairs Manager, you will be responsible for identifying if products are compliant or non-compliant with regulatory requirements and working with new and existing suppliers to improve the company’s supply chain capability. You will report to the Supply Chain Director.

This is a great opportunity to be part of a renowned and growing company in a fast-paced environment. Our client is offering an excellent salary and additional benefits.

This is a permanent position with an immediate start.


Your new job


  • Identifying if products are compliant or non-compliant with regulatory requirements.

  • Manage CE mark submissions, Significant Changes and Notified Body Interactions.

  • Research alternative EU based suppliers.

  • Evaluate changes to the manufacturing and supply chain processes.

  • Approve product labels, package inserts and Marketing material.

  • Lead the Management Review process including the performance of the quality System.

  • Managing of all systems including Design Control, Change Control, CAPA, Risk Management and product Vigilance.


What are we looking for?

  • 3+ years’ experience in a regulatory role is essential.

  • Strong knowledge of ISO 9001 is desirable.

  • Possess strong Technical Writing ability.

  • Ability to digest data, perform analysis and identify trends to make efficient business decisions.

  • Excellent written and verbal communication skills.

  • Excellent attention to detail.

  • A self-starter with excellent time management ability.


Please send cv in word format.

Call David for more information on this job on 0874054758

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