Global Compliance Expert

14 hours ago


Belfast, United Kingdom ARC Regulatory Ltd Full time
About the Role:

This is a fantastic opportunity to join a dynamic team and contribute to the success of our clients in the medical device industry. As an experienced Regulatory Affairs Specialist, you will be responsible for providing expert advice and guidance on regulatory matters, including IVD/CDx development, validation, and approval.

You will work closely with cross-functional teams to ensure that all regulatory requirements are met, and that our clients' products are compliant with relevant regulations. Your expertise will be essential in researching and preparing elements of regulatory submission documents, such as IVDR Annex XIV applications, CTAs, and IDE submissions.

In addition to your technical skills, you will also be required to communicate complex regulatory information to non-technical stakeholders, both internally and externally. Your excellent written and verbal communication skills will be vital in this role.

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