Regulatory Affairs Associate, Product Management

Teleflex Medical Sdn Bhd; Kamunting; On-site; MYR 60,000 - 120,000; Full time

Job summary

Teleflex Medical Sdn Bhd in Kamunting, Perak, seeks a Regulatory Affairs Associate within Product Management to drive regulatory submissions for US FDA, EU NB and Health Canada under supervision. You will prepare and maintain technical files, coordinate licensing activities and support ongoing regulatory compliance.

Join a team focused on quality, compliance, and timely regulatory actions across global markets, with opportunities to engage in product development changes and regulatory strategy.

Qualifications

• Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU NB, Health Canada under supervision.
• Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
• Support regulatory compliance activities, including Health Canada license renewals, FDA device listings, inspections and audits.

Responsibilities

• Generate and maintain regulatory filings for global markets under supervision.
• Coordinate regulatory submissions and license applications with cross‑functional teams.
• Support change control activities and product development impacting regulatory filings.

Job description

Regulatory Affairs Associate, Product Management

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™, LMA™, Pilling™, QuikClot™, 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.

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.

• Generation and maintenance of Technical Files/Technical Documentations and regulatory submissions to U.S. FDA, EU-NB, Health Canada under supervision. Responsible for ensuring the files are in compliance with relevant regulations and standards.
• Assist in regulatory submissions, license applications and amendments (e.g., 510(k), EU MDR, Health Canada) by compiling documents and performing administrative tasks.
• Support the organization in change control activities/ product development for potential impact on current regulatory filings for U.S. FDA, EU-NB, Health Canada. Prepare regulatory assessment/submissions as appropriate.
• Communicate with Regional RA to ensure timely notification of changes as appropriate. Partner with Regional RA to support registration of product in foreign markets. Fulfill basic requests and coordinate with applicable RA staff regarding more complex requests.
• Support regulatory compliance activities, including Health Canada license renewals, Food and Drug Administration (FDA) product device listings, establishment registrations, inspections, audits, etc under supervision
• Review and provide feedback to risk management assessments and design control deliverables, as necessary to ensure that it follows the regulatory requirements under supervision.
• Identify risk factors and contingency planning for assigned projects and communicate to RA management as appropriate
• Review and approve all labeling (product, advertising and promotional) verbiage and evaluate for regulatory impact under supervision
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
• Apply understanding of the quality systems to job activities and projects by adherence to established and evolving internal requirements.
• Brings Regulatory Affairs questions/issues to the attention of RA management and support identification of process improvements for regulatory affairs activities.
• Monitor impact of evolving global regulations regarding submissions, practices, and procedures to regulatory processes.
• Support product registration, tender, license applications and maintain regulatory database as appropriate.
• Coordinate regulatory impact assessments for projects. Communicate the impact and support required for regulatory activities.
• Update and maintain market authorization, execute SAP ship control transactions to release, hold, or end product commercialization for the US and Canadian regions
• Adhere to and ensure the compliance of Teleflex’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Support departmental SOP development and implementation and maintain regulatory files as required by departmental procedure.
• Undertake effective OSH measures to ensure compliance, within the workplace, with the Occupational Safety and Health Act 1994 and other legislative requirements
• Other duties as assigned by the Regulatory Affairs management team

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 is a company that believes in values of Entrepreneurial Spirit, Building Trust and Make It Fun centered around People – our greatest asset.

We are the medical product division of Teleflex Incorporated, a large American MNC, manufacturing and distributing high quality health care products. Our factory is located in Kamunting, Perak and we manufacture sterile disposable medical devices for the urology, anaesthesia and respiratory markets. Our values are focused on customers, growth, leadership and people.

Teleflex is a company that believes in values of Entrepreneurial Spirit, Building Trust and Make It Fun centered around People – our greatest asset.

We are the medical product division of Teleflex Incorporated, a large American MNC, manufacturing and distributing high quality health care products. Our factory is located in Kamunting, Perak and we manufacture sterile disposable medical devices for the urology, anaesthesia and respiratory markets. Our values are focused on customers, growth, leadership and people.

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