Senior Regulatory Affairs Specialist

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My client are a world renowned medical device technology leader. They have been present in Ireland since 1999 with multiple sites here. Over 2500 people are employed in Ireland with most of the company's employees working at the facility in Galway. This site is their centre of excellence for the development and manufacture of a number of the company's key medical technologies for the treatment and management of cardiovascular and cardiac rhythm diseases. They are currently looking for a Senior Regulatory Affairs Specialist to join them.This is a permanent role with great benefits.

What will I be doing as a Senior Regulatory Affairs Specialist?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.What I need to be a Senior Regulatory Affairs SpecialistWe are looking for a qualified person to Level 8 Bachelor's Degree/Masters or equivalent in Science, Engineering or related discipline.Candidates with a minimum of 3 year's relevant experience.You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.If you think the position in Galway is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales