Regulatory Affairs Specialist

Job Overview

Are you looking for an opportunity to join a leading manufacturing company in a Regulatory Affairs role?

Would you want to be part of a company that actively invests in it's employees and promotes from within?

Our client is a leading medical device company based in the sunny South East and is currently looking for a Regulatory Affairs Specialist to join their growing team. This location is within easy reach of Waterford City, Kilkenny, Wexford and South Wicklow.

This role will offer you:
- An opportunity to work with a supportive and friendly team
- A chance to join a company with clear individual development
- An opportunity to work with innovative products and develop global regulatory exposure

You will be responsible for:
- Preparing and maintaining regulatory submissions and documents for key markets
- Ensure regulatory compliance for assigned product lines.
- Coordinating recalls, identifying standards and guidance documents
- Assisting with FDA and internal/external audits

What you'll bring?
- Relevant Degree and 5+ years experience in a regulatory position in the medical device or pharma sector
- Good knowledge of FDA Regulations and ISO Quality Standards
- Strong people skills
- Experience with Quality Systems

This is a great opportunity to join a company and be a key part of their global growth.

An excellent salary package is avaliable for the right candidate.


To apply for this position here are your three options:

1. "This sounds like me" - Call now for a confidential discussing and let's talk through your experience. Call Leo Cordingley on 086 049 5443 between 8am - 8pm.

2. "I think I'm right for this position, but I'm not sure I have enough experience" - Click "apply now" so I can read your profile and let you know.

3. "I'm interested but need to know more about what this job can offer me" - Message me via LinkedIn at with your CV and questions and we'll set up a call to talk.

Key Contact

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