Total 4 job vacancies by Elastomade Accessories Sdn Bhd

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave

醫學、工程、科學或監管領域的學位/文憑

至少 2 年醫療器材產業監管事務經驗

與監管機構打交道的實際經驗（馬來西亞MDA或歐盟等外國授權代表）

良好的組織能力並積極主動地確保滿足監管要求。

良好的溝通能力，與外部和內部利害關係人保持溝通。

良好的英語寫作能力。

ISO 13485 或 GDPMD 的審核經驗將是額外的優勢。

津貼和福利

• 醫療保險
• 事假

Functions:

1. To manage the regulatory compliance function of the company, which include medical device registration, post market surveillance, clinical evaluation.
2. To ensure compliance with regulatory requirements from countries / regions such as the EU (MDR), US (FDA), Malaysia (MDA) and so on.
3. To develop and maintain Technical Documentation for each medical device category.
4. To participate in developing and maintaining Standard Operating Procedures, Work Instructions and Specifications that comply with the relevant regulatory and customer requirements.
5. To keep abreast of the regulatory changes and its implications, keeping management apprised at all times.

Profile:

1. Degree / diploma in medical, engineering, science or regulatory field
2. A minimum of 2 years' experience in regulatory affairs in the medical device industry
3. Practical experience in dealing with regulatory bodies (Malaysia MDA or foreign authorized representative such as the EU)
4. Good organization skills and proactive in ensuring regulatory requirement are met.
5. Good communication skills to maintain communication with external and internal stakeholders.
6. Good written skills in English.
7. Auditing experience in ISO 13485 or GDPMD will be and added advantage.

Perks & Benefits

• Medical insurance
• Personal leave