Regulatory Affairs Executive Port Klang/ Pontian

Role Responsibilities

• Ensure that company’s products comply with the applicable regulations.
• Maintain and update national and international legislation, guidelines and customer practices.
• Collect, collate and evaluate scientific data from a range of sources.
• Develop and write clear arguments and explanations for new product license as well as license renewal.
• Prepare submission of license variations and renewal approvals.
• Monitor and set timeline for license variations and renewal approvals.
• Write clear, accessible product labels and instruction leaflets.
• Involved in post-market surveillance reporting as guided by the Senior Group RA Manager.
• Advise R&D team on regulatory requirements and regulatory strategy.
• Undertake and manage regulatory inspections and technical documentation audit.
• Maintaining the technical documentation and EU declaration of conformity together with Senior Group RA Manager.
• Review company practices and provide advice on changes / improvement to the system.
• Liaise with and make presentations to regulatory authorities.
• Negotiate with regulatory authorities for marketing authorization.
• Specify storage, labelling and packaging requirements (Oversea countries like Taiwan and China).
• Actively involved in company’s environmental initiatives.
• Ensure that target agreed for the KPI’s under the responsibility of the position are achieved.
• To ensure all other duties and projects as assigned by the superior are done.

• Candidate must possess at least a Bachelor’s Degree, Post Graduate Diploma, Professional Degree in Scientific Discipline.
• At least 1-2 year(s) of working experience in the field of medical devices and regulatory affairs on medical devices.
• Analytical and problem solving skills.
• Required Language: Well versed in English, Bahasa Malaysia & Mandarin.
• Full-time position(s) available.
• Candidate must be willing to work in Port Klang, Selangor/ Pontian, Johor.