POSITION SUMMARY

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

EDUCATION / EXPERIENCE 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 / OTHER REQUIREMENTS

• 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 that they are addressed.
• 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)

• 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.
• Preparation of information to support Product Tender Applications in the international markets and to support customer services with the shipment of products.
• Support internal and external audits.
• Support maintenance of product registration database
• Review and evaluate technical and scientific data and reports and incorporate them into documents for submission to regulatory agencies.
• Support regulatory impact assessments for EMEA region.
• Ensure local site regulatory procedures are aligned with global procedures.
• Pursue relevant information pertaining to new developments in regulatory affairs.
• Provide support on other activities as required by immediate supervisor.
• Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.