Quality Assurance Executive

Responsibilities

• 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 ...