Regulatory Affairs Executive – Medical Device

Job Summary:
The Regulatory Affairs Executive is responsible for ensuring that the quality management system (QMS) and all regulatory requirements are maintained and up-to-date. This includes managing and organizing the necessary documentation to ensure compliance with industry standards, regulations, and company policies, particularly in the biomedical engineering sector. The role supports the company in meeting regulatory obligations and contributing to the effective delivery of products and services.

Responsibilities:

• Ensure that all regulatory requirements and documents are maintained in compliance with industry standards. Prepare and maintain records for regulatory filings, product certifications, and other necessary documentation.
• Monitor and ensure the company's adherence to relevant regulations and quality management systems.
• Keep abreast of regulatory changes and ensure the company is fully compliant with local and international regulations.
• Assist in preparing regulatory submissions and managing the approval process. Liaise with regulatory bodies, health authorities, and other stakeholders as required to ensure compliance.
• Collaborate with internal teams to ensure all regulatory documentation is accurate, up-to-date, and complete.
• Support audits and inspections, and help implement corrective actions to address any regulatory gaps.

Requirements:

• A degree in science or a related field; a biomedical engineering degree is an advantage.
• More than 2 years of experience in regulatory affairs within the medical or biomedical industry.
• Proficiency in both written and verbal English.
• Strong understanding of the GDPMD (Good Distribution Practice for Medical Devices) and MDA (Medical Device Authority) Act.
• Familiarity with Quality Management Systems (QMS) such as ISO 9001 and ISO 13485 is an advantage.
• Excellent attention to detail and strong organizational skills.
• Ability to interpret and apply regulatory standards and guidelines.
• Ability to work independently and within cross-functional teams.

Benefits

• Sustainable & undisrupted industry (Healthcare).
• Key crew in a fast-growing organization
• Conducive & comfortable work environment.
• Long term job placement.
• Yearly performance-based increment.
• Yearly bonus.

Job Types: Full-time, Contract
Contract length: 36 months

Pay: RM2,000.00 - RM2,800.00 per month

Benefits:

• Additional leave
• Maternity leave
• Professional development

Schedule:

• Monday to Friday

Supplemental Pay:

• Performance bonus
• Yearly bonus

Experience:

• Regulatory Affairs: 2 years (Preferred)

Location:

• Ipoh (Preferred)