​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

Responsibilities:

• 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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