Senior Regulatory Affairs Specialist
Work with one of the world’s largest medical device companies as part of their ever-growing plant here in Galway where they have developed a focus for innovation and product excellence to deliver best-in-class solutions.
- Work as part of the wider RA team supporting NPI and NPD projects while also working on change controls for existing product lines
- Provide technical expertise to resolve any potential regulatory issues from regulatory agencies
- Prepare regulatory submissions for new products and product changes to ensure timely approvals for market release and clinical studies
- Work on global recertification and compliance for labels and marketing materials
- Prepare submissions and reports for EU and US regulatory agencies
- Build a strong relationship with external regulatory bodies
- Identify and implement best practices for the RA Department
- Assist in post market surveillance support for commercial products
- Level 8 bachelor’s degree or level 9 master’s degree in science or similar discipline
- Must have 5 years or more in regulatory affairs or have similar experience
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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