Regulatory Affairs Specialist
- Posted 23 May 2023
- LocationCounty Offaly
- Job type Permanent
- DisciplineSupply Chain
- Reference10167-M
- 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
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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