At Teleflex, we are a global provider of medical technologies driven by our purpose to improve the health and quality of people's lives. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
We offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology through our trusted brands Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck.
Job Summary
Support the regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in the EMEA region.
The successful candidate will be responsible for coordinating and managing regulatory and product registration activities. This includes preparing internal reports and change control documents, reviewing documents for potential impact on global regulatory submissions, and preparing product registration files for submission to global regulatory bodies/agencies.
* Coordination and management of regulatory and product registration activities.
* Responsible for providing RA input for projects in a timely manner.
* Preparation of internal reports and change control documents, and the review of documents for potential impact on global regulatory submissions.
* Preparation of product registration files for submission to global regulatory bodies/agencies to obtain product approvals and maintain regulatory compliance with international regulatory requirements.
* Participation in project work such as new product introductions, changes to existing products and processes, and other regulatory/company projects as required.
The ideal candidate will have a degree in a relevant Science or Engineering discipline and 2-3 years medical device industry experience within quality or regulatory. They should also have technical writing expertise and basic knowledge and understanding of US and/or international medical device regulations, standards and guidance documents.
This is an exciting opportunity for a self-driven and able individual who can work independently and/or as a team player. They should be approachable and enthusiastic, flexible and adaptable, with good organisational skills and cultural awareness and sensitivity.
The position requires up to 10% travel, with a hybrid model including 3 days onsite in Athlone office. We are committed to diversity and inclusion and welcome applications from candidates from all backgrounds.