Senior Regulatory Affairs Specialist
Are you looking for an opportunity to join a leading medical device company in a senior Reg 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 Galway and is currently looking for a Senior Regulatory Affairs Specialist to join their growing team. This has come about due to company growth and helping to expand their portfolio of products.
This role will offer you:
- An opportunity to work with new product development
- A chance to join a company with clear individual development
- An opportunity to work with highly invasive 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
- Good knowledge of FDA Regulations and ISO 13485 Quality Standards
- Strong people skills
- Experience with writing regulatory submissions
This is a great opportunity to join a company and be a key part of their global growth.
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 https://www.linkedin.com/in/lcordingley/ with your CV and questions and we'll set up a call to talk.