Regulatory Affairs Team Lead

Date : 22 Aug 2025

Location : Kamunting, 08, MY

Company : Teleflex

Expected Travel : None

Requisition ID : 12589

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

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

Principal Responsibilities

• Support generation and maintenance of Technical Files / Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada. Responsible for ensuring the files are in compliance with relevant regulations and standards.
• Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
• Support the organization in change control activities for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment / submissions as appropriate.
• Support regulatory agency and / or notified body audits by as needed.
• Participate in development and approval of risk activities as well as other deliverables as related to projects.
• Review and approve Clinical Evaluation, PMCF, SSCP development and updates to achieve regulatory compliance.
• Provide regulatory input to product lifecycle planning.
• Support regulatory tasks and strategic initiatives, and recommend solutions to address potential regulatory and quality issues.
• Review and approval of all labeling (product, advertising and promotional), considering potential regulatory impact, and clinical evaluations.
• Support CAPAs, NCs, and other quality efforts, as needed.
• Assist in regulatory due diligence process, as needed.
• Lead departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
• Monitor impact of evolving global regulations regarding submissions, practices, and procedures and to regulatory processes and internal stakeholders.
• Support RA Manager with other regulatory tasks and initiatives. Propose solutions for Regulatory Affairs questions / issues to RA management, as necessary
• Oversee product registration, tender and license applications.
• Prepares monthly reports to RA management
• Adhere to Code of Ethics for Regulatory professionals.
• Comply with Teleflex's Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
• Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements

Education / Experience Requirements

Specialized Skills / Other Requirements

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.

2025 Teleflex Incorporated. All rights reserved.