Regulatory Affairs Quality Assurance Executive

2 days ago

Port Klang, Malaysia ELASTOMADE ACCESSORIES SDN BHD Full time

**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.

**Perks & Benefits**
- Medical insurance
- Personal leave

Pay: RM3,500.00 - RM5,500.00 per month

**Benefits**:

- Free parking
- Health insurance

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Port Klang: Reliably commute or planning to relocate before starting work (preferred)

**Location**:

- Port Klang (preferred)

Application Deadline: 10/12/2024

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