Global Regulatory Affairs Associate

Teleflex; Kamunting; Presencial; MYR 60.000 - 90.000; Tempo integral

Resumo da vaga

Teleflex seeks a Regulatory Affairs Associate to join Global Operations. The role focuses on generating and maintaining regulatory submissions to FDA, EU NB, and Health Canada, with support for license applications and amendments.

You will collaborate with regional teams to register products internationally and ensure compliance across labeling and documentation. The ideal candidate holds a science or engineering degree and demonstrates strong communication, organization, and regulatory

Qualificações

• Bachelor’s degree in science or engineering or equivalent experience.
• Knowledge of regulatory submission processes and documentation.
• Ability to interact professionally with diverse teams and regulators.
• Proven organizational and time management skills.
• Strong communication and analytical abilities are required.

Responsabilidades

• Generate and maintain Technical Files and regulatory submissions to FDA, EU NB, Health Canada.
• Assist with license applications and amendments and compile supporting documents.
• Support change control activities and product development for regulatory impact.
• Coordinate with Regional RA for registration of products in foreign markets.
• Support Health Canada licenses renewals and FDA listings under supervision.
• Review labeling for regulatory impact and ensure compliance with guidelines.
• Identify risk factors and prepare regulatory assessments for projects.
• Monitor evolving global regulations affecting submissions and processes.
• Update regulatory databases and assist in product registrations and tenders.

Conhecimentos

Confidentiality

Communication

Analytical thinking

Time management

Multitasking

Regulatory knowledge

Formação

Bachelor’s degree in science or engineering

Ferramentas

Microsoft Office

Word

PowerPoint

Excel

Outlook

Teams

Descrição da vaga

Teleflex seeks a Regulatory Affairs Associate to join Global Operations. The role focuses on generating and maintaining regulatory submissions to FDA, EU NB, and Health Canada, with support for license applications and amendments.

You will collaborate with regional teams to register products internationally and ensure compliance across labeling and documentation. The ideal candidate holds a science or engineering degree and demonstrates strong communication, organization, and regulatory