Senior Regulatory Affairs Associate

JOB PURPOSE:

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

PRINCIPAL RESPONSIBILITIES:

Key responsibilities will include (but are not limited to) the following:

• Coordination and management of regulatory and product registration activities for the EMEA region

• 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.

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 EU and international medical device regulations, standards and guidance documents.

• Project Management skills and experience.

OTHER SKILLS / 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.

• Pharmaceutical and/or Drug/ Device Combination device experience and Clinical expertise an advantage.

Key Relationships / Interfaces:

• Global QARA

Behaviours & Values:

TRAVEL REQUIRED: Approx 10% travel required

Applicants must have the legal right to work in the Kingdom of Saudi Arabia at the time of application. This includes holding valid residency and work authorisation documentation, or being a Saudi national eligible for employment under applicable law.

In accordance with the Kingdom's Nitaqat programme and Ministry of Human Resources and Social Development requirements, Teleflex [is committed to the employment and professional development of Saudi nationals. Priority consideration will be given to qualified Saudi national candidates as part of our commitment to supporting the Kingdom's nationalisation objectives. Teleflex] actively encourages applications from Saudi nationals for this position.