At Teleflex, we are a global provider of medical technologies driven by our purpose to improve the health and quality of people's lives. Our vision is to become the most trusted partner in healthcare.
We offer a diverse portfolio with solutions in various therapy areas, including anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology.
Our belief is that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Job Title: Regulatory Affairs Specialist
Position Summary:
This role supports regulatory activities leading to and maintaining regulatory compliance and approval for Teleflex Medical products in the EMEA region.
Key Responsibilities:
* Coordination and management of regulatory and product registration activities.
* Providing RA input for projects in a timely manner.
* Preparation of internal reports and change control documents, and 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.
* Preparation of information to support Product Tender Applications in international markets and to support customer services with shipment of products.
* Supporting internal and external audits.
* Maintenance of product registration database.
* Review and evaluation of technical and scientific data and reports and incorporation into documents for submission to regulatory agencies.
* Regulatory impact assessments for EMEA region.
* Alignment of local site regulatory procedures with global procedures.
* Pursuit of relevant information pertaining to new developments in regulatory affairs.
* Support on other activities as required by immediate supervisor.
Requirements:
* Degree in a relevant Science or Engineering discipline required.
* 2-3 years medical device industry experience within quality or regulatory desired.
* Technical writing expertise.
* Basic knowledge and understanding of US and/or international medical device regulations, standards and guidance documents.
* Project Management skills and experience.
Specialized Skills:
* Self-driven and ability to work independently and/or as a team player.
* Approachable and enthusiastic. Flexible and adaptable.
* Able to work on own initiative and as a team player.
* Good organisational skills with cultural awareness and sensitivity.
* Good judgment and problem-solving ability & capable of understanding the impact of decision making on both Teleflex and customers.
* Excellent Communication skills both written and verbal.
* Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved.
* Communicate concerns effectively to the RA Manager and project teams to ensure they are addressed.
* Participation in project meetings to provide regulatory inputs during the planning, execution and closure of the projects.
Travel Requirements:
Up to 10% (Hybrid model - 3 days onsite in Athlone office is a must)
Diversity and Inclusion:
We believe diversity fosters innovative thinking and entrepreneurship. We trust and value our people and their diversity and make it fun to work here.
Disclaimer:
We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.