Regulatory Affairs Executive

UMMI Surgical Sdn Bhd; Shah Alam; On-site; MYR 65,000 - 95,000; Full time

Benefits offered by this job

13-month salary

Medical insurance

Health screening and dental subsidy

Continuous training and development

Collaborative working environment

Job summary

UMMI Surgical Sdn Bhd, a trusted medical device solutions provider in Malaysia, seeks a Regulatory Affairs Executive to manage registrations, ensure MDA and GDPMD compliance, and maintain the QMS across the organization.

The role involves preparing regulatory submissions, coordinating audits, and liaising with authorities and internal teams to ensure timely approvals and high-quality documentation.

Qualifications

• Degree in Life Sciences, Biology, Chemistry, Biomedical Science or related field.
• Experience in Regulatory Affairs, GDPMD or the medical device industry is an advantage.
• Familiarity with MDA regulations, GDPMD requirements and medical device registrations.

Responsibilities

• Handle medical device product registrations, renewals, and change notifications with the Medical Device Authority (MDA).
• Apply for, maintain, and renew the company's Establishment Licence and other regulatory approvals.
• Prepare and submit regulatory applications and follow up on authority queries through to approval.
• Develop, review, and maintain Quality Manuals, SOPs, forms and related quality documentation.
• Ensure the QMS is implemented, maintained, and improved per GDPMD requirements.
• Coordinate and monitor QMS activities, including document control, CAPA, and continuous improvement.
• Liaise with external parties on regulatory and quality matters.
• Support audits, inspections, and certifications and follow up on findings.
• Work with internal departments to ensure regulatory compliance.

Skills

Regulatory affairs

GDPMD knowledge

MDA regulations

Quality documentation

MS Office

Education

Bachelor in Life Sciences/related field

Tools

Microsoft Office

Job description

Location: HQ – Glenmarie, Shah Alam | Medical Device Industry

Do you have strong attention to detail and an interest in regulatory compliance? Join UMMI Surgical Sdn Bhd, a trusted provider of medical devices and healthcare solutions.

In this role, you will be responsible for managing product registrations, ensuring compliance with Medical Device Authority (MDA) requirements, and maintaining the Quality Management System (QMS) in accordance with GDPMD standards. You will play an important role in supporting the delivery of compliant and high-quality medical devices to healthcare providers throughout Malaysia.

Key Responsibilities

Handle medical device product registrations, renewals, and change notifications with the Medical Device Authority (MDA).

Apply for, maintain, and renew the company's Establishment Licence and other regulatory approvals.

Prepare and submit regulatory applications and follow up closely on authority queries through to approval.

Develop, review, and maintain Quality Manuals, SOPs, forms and related quality documentation.

Ensure the Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with GDPMD requirements.

Coordinate and monitor QMS activities, including document control, corrective and preventive actions (CAPA), and continuous improvement initiatives.

Liaise with external parties on regulatory and quality-related matters.

Support internal and external audits, inspections, and certification activities and ensure timely follow-up on audit findings.

Work closely with internal departments to ensure compliance with regulatory, quality, and company requirements.

Promote awareness of regulatory and quality requirements throughout the organisation.

Maintain accurate regulatory records, licences, registrations and quality documentation.

What We Offer

• Competitive salary package
• 13-month salary
• Medical, hospitalization & life insurance coverage
• Annual health screening, dental & optometry subsidy
• Continuous training and professional development
• Supportive and collaborative working environment

Qualifications & Requirements

Degree in Life Sciences, Biology, Chemistry, Biomedical Science or related field

Experience in Regulatory Affairs, GDPMD or the medical device industry will have an added advantage

Good knowledge of MDA regulations, GDPMD requirements and medical device registration processes is preferred

Proficient in Microsoft Office applications (Word, Excel, and PowerPoint)

Proficient in English and Bahasa Malaysia (written and spoken)

Responsible, detail-oriented, organised and able to manage multiple tasks effectively

Positive attitude with good interpersonal and teamwork skills

UMMI Surgical Sdn Bhd is the exclusive partner for some of the world's biggest manufacturers of medical / surgical devices; and is one of the leading entity in the surgical and medical industry in Malaysia.

With dedicated teams working together sharing the same objective: to deliver values and serve customers in the most professional manner; UMMI Surgical has become the partner trusted by customers who value professional conduct and reliability of service.

We believe in providing our people with a safe & pleasant working environment. Join us if you believe good work should be rewarded; and if you believe good employees deserve a good employer. We offer a career, not just a job.

What can I earn as a Regulatory Affairs Executive