Medical Device Regulatory Affairs Specialist

3 days ago


Dublin, Dublin City, Ireland Teleflex Full time

Company Overview

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Teleflex is a global provider of medical technologies driven by our purpose to improve the health and quality of people's lives. We offer a diverse portfolio with solutions in various therapy areas, including anesthesia, emergency medicine, interventional cardiology, radiology, surgical, vascular access, and urology.

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We believe that great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Our trusted brands, such as Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift, and Weck, are united by a common sense of purpose.

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Job Description

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The Sr. Regulatory Affairs Associate will support regulatory activities leading to and maintaining regulatory compliance and approval for Teleflex Medical products in the EMEA region. Key responsibilities include coordinating and managing regulatory and product registration activities, providing RA input for projects, preparing internal reports and change control documents, and reviewing documents for potential impact on global regulatory submissions.

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This role also involves preparing product registration files for submission to global regulatory bodies/agencies, participating in project work such as new product introductions and changes to existing products and processes, and supporting maintenance of product registration database.

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Required Skills and Qualifications

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To be successful in this role, you should have a degree in a relevant Science or Engineering discipline and 2-3 years of medical device industry experience within quality or regulatory. Technical writing expertise and basic knowledge of US and/or international medical device regulations, standards, and guidance documents are also essential.

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Project Management skills and experience are required, along with self-driven and ability to work independently and/or as a team player. Good organisational skills with cultural awareness and sensitivity, good judgment, and problem-solving ability are also necessary.

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Benefits

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As a Sr. Regulatory Affairs Associate at Teleflex, you will have the opportunity to work on exciting projects and collaborate with a talented team of professionals. You will also receive competitive compensation and benefits package.

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Others

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Teleflex is an equal opportunity employer and values diversity and inclusivity in the workplace. If you require accommodation and support to apply for a position, please contact us.

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We follow a comprehensive hiring process and do not accept unsolicited resumes from agency recruiters or 3rd party firms.



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