​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

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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