RA Executive

KLS Martin SE Asia Sdn Bhd; Simpang Ampat; On-site; MYR 65,000 - 90,000; Full time

Job summary

KLS Martin SE Asia Sdn Bhd in Penang is seeking a Regulatory Affairs/Quality Assurance professional to manage and monitor product registrations for the SE Asia region. You will liaise with corporate, regional and local partners to ensure documentation and compliance, maintain all registration files, and support audits.

The role requires 2–3 years in regulatory affairs/QA, familiarity with ISO 13485 and local regulations, strong English communication, and the ability to work with minimal

Qualifications

• Minimum qualification is Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree or equivalent.
• 2–3 years of working experience in Regulatory Affairs/Quality Assurance.
• Familiar with ISO 13485, Malaysia Medical Device Act and Regulations, Good Distribution Medical Device Practice, ASEAN Medical Device Directive.

Responsibilities

• Prepare, submit and monitor product registration for SE Asia region.
• Liaise with corporate, regional and/or local partners to ensure all documents required for registration are completed and compliance.
• Ensure maintenance of all registration files.
• Liaise with sales division on sales and marketing strategies for new product launches.
• Reports to local authorities on post market surveillance such as Adverse Event Reporting and FSCA.
• Provide latest regulatory information to the team.
• Ensuring compliance with Malaysia MDA requirements.
• Ensuring the promotion of awareness of regulatory requirements throughout the organization.
• Support on-site audits conducted by external providers.

Skills

Regulatory affairs

Quality Assurance

English proficiency

Communication skills

Independent working

Education

Diploma/Advanced Diploma/Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Job description

1.Prepare, submit and monitor product registration for SE Asia region.

2.Liaise with corporate, regional and/or local partners to ensure all documents required for registration are completed and compliance. Follow up on registration applications constantly and timely manner.

3.Ensure maintenance of all registration files.

4.Liaise with sales division on sales and marketing strategies for new product launches.

5.Reports to local authorities on post market surveillance such as Adverse Event Reporting and Field Safety Corrective Action (FSCA).

6.Provide latest regulatory information to the team

7.Ensuring compliance with Malaysia MDA requirements

8.Ensuring the promotion of awareness of regulatory requirements throughout the organization

9.Support on-site audits conducted by external providers.

10.Other duties as and when assigned.

QUALIFICATION/EDUCATION BACKGROUND

• Minimum qualification is Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree or equivalent.

EXPERIENCES

• Possess with at least 2 to 3 years of working experience in Regulatory Affairs/Quality Assurance.

PREFERRED KNOWLEDGE

• Familiar with
• ISO 13485.
• Malaysia Medical Device Act and Regulations.
• Good Distribution Medical Device Practice.
• ASEAN Medical Device Directive.
• Meticulous with multi-tasking ability and organized.
• Proficient in Microsoft Office applications especially Word and Excel files.
• Confident, mature, resourceful with a pleasant personality and willingness to learn.
• Good communication skills with possess the good oral and written skills. Proficiency in English is essential.
• Able to work under minimal supervision.