What you need to know
I am looking for a Senior Regulatory Affairs Specialist to work at a global Medical Device in Galway. who will be responsible for managing regulatory submission activities for product maintenance for existing approved products, ensuring that all products comply with Global Regulations and International Standards.
This is a permanent job that comes with a competitive salary and benefits package.
Your new job
As part of a team of regulatory affairs professionals you provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Key duties & responsibilities:
- Prepare regulatory submissions for new products and product changes as required to ensure timely approvals for market release and/or clinical studies.
- Provide post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval
- Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
- Interact directly with external regulatory agencies (FDA, notified bodies etc.) and/or indirectly with international regulatory agencies on applicable projects/products.
- Develop internal procedures to ensure continuous compliance with all regulatory requirements
What are we looking for?
- We are looking for a qualified person to Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering or related discipline
- Regulatory experience is desirable, however, candidates with a minimum of 5 year’s relevant experience will also be considered.
- You set high standards and drive accountability in the execution of your responsibilities and you model ethical behaviour.
- You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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