Malaysia Job Openings
ELASTOMADE ACCESSORIES SDN BHD
Regulatory Affairs Quality Assurance Executive (RAQA Executive)
FULL TIME
October 8, 2024
- 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.
- 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.
- Medical insurance
- Personal leave
Pay: RM3,500.00 - RM5,500.00 per month
Benefits:
- Free parking
- Health insurance
- Monday to Friday
- Port Klang: Reliably commute or planning to relocate before starting work (Preferred)
- Port Klang (Preferred)
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