Expected Travel: More than 50%

Requisition ID: 12470

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. 
 
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
 
At Teleflex, we are empowering the future of healthcare.  For more information, please visit teleflex.com.

Position Summary

Creates and executes regulatory strategies for Taiwan & Hong Kong registrations and participates in any resultant compliance activities.

Principal Responsibilities

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

Participate and coordinate in the development of regulatory strategies, in conjunction with the needs of the company, for each product range and change. Establish regular review with Sales & Marketing and other relevant stakeholders to ensure the strategies are in alignment with company needs and marketing strategy. Identify risks and/or changes to the strategies (if any) and involve the relevant stakeholders for discussion on action plan. Liaise with the necessary parties, Global RA, registration agents, distributors, sales & marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for designated market. 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 the technical documents obtained from different source before submission to external party and/or authority to ensure the documents meet and/or fulfil the country requirement/request. Ensure the documents are legalized and/or notarized where required. Monitor and update registration activities and/or status to all relevant stakeholders in regular basis. Ensure the required actions and responses are in place in a timely manner. Identify and report any delay to the registration timeline and involve the relevant stakeholders for discussion on action plan. Ensure timely approval of registration in targeted markets. Identify risks and propose options/solutions to relevant stakeholders and management. Manage changes to licenses due to product/manufacturing related changes to minimize or prevent risk/impact to business. Ensure proper processes are in-place to ensure effective management of changes with consideration of inventories cut in in accordance with license approval. Monitor license & QSD validity, maintain license & QSD database, and ensure license & QSD renewal to be conducted in a timely manners. Manage import authorization for the authorized distributors to ensure smooth importation. Participates and supports team in business interactions and negotiations with regulatory agencies on submission requirements, labelling claims, etc. Monitor and interpret regulatory updates relevant to medical devices, assess the potential impact on business operations and product compliance, and develop strategic responses to ensure adherence to applicable laws and standards. Ensure timely update new UDI to TUDID. Support tender document requests from distributors and Go-Direct business. Education / Experience Requirements Min. Diploma/bachelor’s degree in science Discipline Min 3-5 years regulatory experience working in a medical company Individuals who have worked in TFDA are a plus. Individuals who have completed Taiwan registration submission (New product/QSD or amendment). Detail oriented, with emphasis on accuracy and completeness Good English written and reading skills, and moderate in English speaking. Good organizational and planning skills; drives for results Effective analytical/problem solving skills Good interpersonal skills that include working well in a team environment and the ability to lead others. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. Ability to identify areas of concern in moderately complex projects and manage change Computer literacy (PC, Microsoft Word/Excel/PowerPoint) Specialized Skills / Other Requirements Possess good organizational and analytical skills Team player with hands on experience in related field Pragmatic and able to think and operate inter-departmentally and not lose sight of priorities in the hectic day-to-day operations Possess a high level of communicative skills, the ability to persuade and self-assertion Ability to work under pressure analytically and systematically Quick comprehension, thinking in terms of the big picture and organizational skills Ability to integrate and get along with people of differing backgrounds and agendas Ability to quickly establish credibility at all levels in the organization

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time. 

Teleflex is an equal opportunities employer.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. 
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