Senior Regulatory Affairs Specialist in a well known Med Device company
I am delighted to be working with a well known Medical Device company in Galway. This is an exciting role for someone in the Reg Affairs sectory.
- 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.
- 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. This includes supporting global re-certification activity, reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for filing directly with EU & US regulatory agencies and support other international agencies as required by product status.
- Interact directly with external regulatory agencies (FDA, notified bodies etc.) and/or indirectly with international regulatory agencies on applicable projects/products.
- Support regulatory compliance activities, including manufacturing site registration & regulatory agency audits as needed.
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Develop internal procedures to ensure continuous compliance with all regulatory requirements.
- Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
- Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
KEY SKILLS & EXPERIENCE
- 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 are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
- You are experienced with Microsoft Word, Excel and PowerPoint, and knowledge of Adobe Acrobat, Data Management Systems are desirable
- You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- You collaborate with others and create alignment with team members.
- You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
- You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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