Regulatory Affairs Specialist

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care.

The Regulatory Affairs Specialist contributes to regulatory aspects associated with the US, Canada and European markets for the Surgical business unit. This position is responsible for authoring submissions, participating on project / design teams, managing questionnaire requests from regional affiliates and distributors. Additional expectations include staying abreast of evolving regulatory requirements and / or standards in specific area(s) of concentration (countries) as assigned.

* Participate as a member of the regulatory team within the business unit to implement the “regulatory strategic plan”. * Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of submissions for new products, amendment/variation of approved products and submissions that support the maintenance of existing licenses. * Review technical documents intended for submission. * Author Clinical Evaluations in conjunction with Medical Affairs **R&D Interface** * Review technical and scientific data to ensure that it follows the regulatory requirements, providing guidance to marketing and design teams. * Product / Process Quality Standards * Apply understanding of the quality systems to job activities and projects. **Communication with Regulators** * Participate in regulatory meetings to get familiar with the negotiation process. * Submission Management * Assist the preparation and maintenance of moderate-complexity regulatory submissions while maintaining quality standards. * Prepare responses to standard questions and comments from regulatory agencies and ensure issues are addressed in a timely manner. * Begin to identify potential risks in submissions **Internal and External Influence and Advocacy Development.** * Understand regulatory processes, guidelines and guidance documents and what they mean to the organization **Risk Assessment and Contingency Planning** * Identify risk factors and contingency planning for assigned projects.

• Bachelor’s degree, preferably in a scientific discipline • 2-3 years regulatory experience • Experience working for a medical device manufacturer and/or working in a FDA or ISO regulated environment preferred. **SPECIALIZED SKILLS & OTHER REQUIREMENTS:** Additional preferred or required qualifications. •Knowledge and experience in one or more essential regulatory areas and marketing approvals; change assessment; advertising and promotional labeling; and quality systems. •Knowledge of and ability to interpret applicable in -country regulations. •Excellent written and verbal communication skills and computer literacy are required. •Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality are essential.