Global Regulatory Affairs Specialist

Teleflex Medical Sdn Bhd; Kamunting; Presencial; MYR 60 000 - 120 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Descrição da oferta de emprego

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.