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Sr. Regulatory Affairs Associate

1 month ago

Athlone, County Westmeath, Ireland Teleflex Full time
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in 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. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.

Teleflex is the home of Arrow, Barrigel, Deknatel, QuikClot, LMA, Pilling, Rüsch, UroLift and Weck – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Position Summary

Support the regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in the EMEA region.

1. Coordination and management of regulatory and product registration activities.
2. Responsible for providing RA input for projects in a timely manner.
3. Preparation of internal reports and change control documents, and the review of documents for potential impact on global regulatory submissions.
4. Preparation of product registration files for submission to global regulatory bodies/agencies to obtain product approvals and maintain regulatory compliance with international regulatory requirements.
5. Participation in project work such as new product introductions, changes to existing products and processes, and other regulatory/company projects as required.
6. Preparation of information to support Product Tender Applications in the international markets and to support customer services with the shipment of products.
7. Support internal and external audits.
8. Support maintenance of product registration database.
9. Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to regulatory agencies.
10. Support regulatory impact assessments for EMEA region.
11. Ensure local site regulatory procedures are aligned with global procedures.
12. Pursue relevant information pertaining to new developments in regulatory affairs.
13. Provide support on other activities as required by immediate supervisor.
14. Adhere to and ensure the compliance of Teleflex's Code of Ethics, all company policies, rules, procedures, and housekeeping standards.

Education / Experience Requirements

1. Degree in a relevant Science or Engineering discipline required.
2. 2-3 years medical device industry experience within quality or regulatory desired.
3. Technical writing expertise.
4. Basic knowledge and understanding of US and/or international medical device regulations, standards and guidance documents.
5. Project Management skills and experience.

Specialized Skills / Other Requirements

1. Self-driven and ability to work independently and/or as a team player.
2. Approachable and enthusiastic. Flexible and adaptable.
3. Able to work on own initiative and as a team player.
4. Good organisational skills with cultural awareness and sensitivity.
5. Good judgment and problem-solving ability & capable of understanding the impact of decision making on both Teleflex and customers.
6. Excellent Communication skills both written and verbal.
7. Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
8. Communicate concerns effectively to the RA Manager and project teams to ensure that they are addressed.
9. Participate in project meetings to provide regulatory inputs during the planning, execution and closure of the projects.

Travel: Up to 10% (Hybrid model - 3 days onsite in Athlone office is a must)

#LI-hybrid

Teleflex is an equal opportunity employer. Applicants will be considered without regard to age, gender, race, nationality, ethnicity, civil status, family status, sexual orientation, disability, religion and/or membership of the traveller community.

If you require accommodation and support to apply for a position, please contact us at talent.emea@teleflex.com.

Diversity fosters innovative thinking and entrepreneurship and that's what we are about at Teleflex. We trust and value our people and their diversity and we make it fun to work here. We are on a journey to ensure our workplaces mirror the patients we serve and the communities we operate in. Our approach is simple, we embrace everyone and want them to feel they belong here. We are building a culture where all employees can bring their best and unique selves to work. If that appeals to you, we would love to hear from you. Come join a company where diversity is sought out and inclusivity is how we progress.

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