Regulatory Affairs Specialist / Executive

Functions: To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on. To develop and maintain Technical Documentation for each medical device category. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times. Profile: Degree / diploma in medical, engineering, science or regulatory field A minimum of 2 years' experience in regulatory affairs in the medical device industry Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU) Good organization skills and proactive in ensuring regulatory requirement are met. Good communication skills to maintain communication with external and internal stakeholders. Good written skills in English. Auditing experience in ISO 13485 or GDPMD will be and added advantage.
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