Regulatory Affairs Specialist- Latin America

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 incumbent in this role manages regulatory aspects associated with Latin America product registrations and is responsible for regulatory strategies, submissions, and for managing interactions with various regulatory agencies. The incumbent is also responsible for staying abreast of evolving regulatory requirements 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.” * Participate as a member of “Technical Teams” for new and/or existing products. Evaluate and interpret regulatory requirements to meet project needs. * 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. * Develop timelines, coordinate receipt of technical information from appropriate sources and manage the preparation of responses to regulatory agency questions and/or requests for information. * Review technical documents intended for submission. * Train, develop, and mentor co-workers as appropriate. * Develop regulatory strategies for product development and launch of moderate-complexity projects. * Conduct and analyze regulatory research for moderate-complexity projects to understand competitor activity and positioning, and translate to regulatory strategy. * Provide guidance to project teams for existing research and standard analysis. * Review technical and scientific data to ensure that it follows the regulatory requirements. * Apply understanding of the quality systems to job activities and projects. * Participate in training RA team members and others on compliance matters. * Participate in regulatory meetings to ensure familiarity with the negotiation process. * Communicate with regulatory agencies on administrative and routine matters or to address questions on specific submissions. * Assist or lead 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. * Identify any potential risks in submissions. * Interpret existing regulations and guidance documents within regulatory department and on project teams. * Understand regulatory processes, guidelines and guidance documents and what they mean to the organization. * Identify risk factors and contingency planning for assigned projects.

* B.A. or B.S. degree in the life sciences, or similar field, may be substituted by extended experience in regulatory field * Minimum 3 years of medical device experience as a regulatory specialist in international regulatory affairs.