Position Summary
Support the regulatory activities which lead to and maintain regulatory compliance and approval for Teleflex Medical products in the EMEA region.
Responsibilities
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 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 the 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 the 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.
Specialized Skills / Other Requirements
Self-driven and ability to work independently and/or as a team player.
Approachable and enthusiastic.
Flexible and adaptable.
Good organisational skills with cultural awareness and sensitivity.
Good judgment and problem-solving ability and 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.
Equal Opportunity and Accommodation
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
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